Trial Outcomes & Findings for Impact of Sleep Restriction on Performance in Adults (NCT NCT02960776)

NCT ID: NCT02960776

Last Updated: 2025-04-03

Results Overview

Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Week 6 (endpoint)

Results posted on

2025-04-03

Participant Flow

Participant milestones

Participant milestones
Measure
Adequate Sleep Followed by Sleep Restriction
Participants were randomized to continue adequate sleep in phase 1 and crossed over to sleep restriction condition in phase 2
Sleep Restriction Followed by Adequate Sleep
Participants were randomized to restrict sleep in phase 1 and crossed over to follow their habitual adequate sleep in phase 2
Overall Study
STARTED
22
23
Overall Study
COMPLETED
16
20
Overall Study
NOT COMPLETED
6
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI data were not obtained in one participant at baseline of phase 1 for sleep restriction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Adequate Sleep Followed by Sleep Restriction
n=22 Participants
Participants were randomized to continue adequate sleep in phase 1 and crossed over to sleep restriction condition in phase 2
Sleep Restriction Followed by Adequate Sleep
n=23 Participants
Participants were randomized to restrict sleep in phase 1 and crossed over to follow their habitual adequate sleep in phase 2
Total
n=45 Participants
Total of all reporting groups
Age, Continuous
32.5 years
STANDARD_DEVIATION 12.3 • n=22 Participants
31.6 years
STANDARD_DEVIATION 11.4 • n=23 Participants
32.0 years
STANDARD_DEVIATION 11.7 • n=45 Participants
Sex: Female, Male
Female
9 Participants
n=22 Participants
13 Participants
n=23 Participants
22 Participants
n=45 Participants
Sex: Female, Male
Male
13 Participants
n=22 Participants
10 Participants
n=23 Participants
23 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=22 Participants
16 Participants
n=23 Participants
22 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=22 Participants
7 Participants
n=23 Participants
23 Participants
n=45 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=22 Participants
0 Participants
n=23 Participants
0 Participants
n=45 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=22 Participants
1 Participants
n=23 Participants
1 Participants
n=45 Participants
Race (NIH/OMB)
Asian
3 Participants
n=22 Participants
1 Participants
n=23 Participants
4 Participants
n=45 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=22 Participants
0 Participants
n=23 Participants
0 Participants
n=45 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=22 Participants
7 Participants
n=23 Participants
9 Participants
n=45 Participants
Race (NIH/OMB)
White
13 Participants
n=22 Participants
8 Participants
n=23 Participants
21 Participants
n=45 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=22 Participants
1 Participants
n=23 Participants
3 Participants
n=45 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=22 Participants
5 Participants
n=23 Participants
7 Participants
n=45 Participants
Region of Enrollment
United States
22 participants
n=22 Participants
23 participants
n=23 Participants
45 participants
n=45 Participants
Body fat volume by MRI
23.9 Liter
STANDARD_DEVIATION 10.1 • n=22 Participants • MRI data were not obtained in one participant at baseline of phase 1 for sleep restriction
24.6 Liter
STANDARD_DEVIATION 11.4 • n=22 Participants • MRI data were not obtained in one participant at baseline of phase 1 for sleep restriction
24.3 Liter
STANDARD_DEVIATION 10.7 • n=44 Participants • MRI data were not obtained in one participant at baseline of phase 1 for sleep restriction
Sedentary Behavior
741 minutes/day
STANDARD_DEVIATION 94 • n=22 Participants
752.4 minutes/day
STANDARD_DEVIATION 93.4 • n=23 Participants
746.4 minutes/day
STANDARD_DEVIATION 93.8 • n=45 Participants
Physical Activity
103.6 minutes/day
STANDARD_DEVIATION 49.5 • n=20 Participants • Data were not available for 5 participants.
89.3 minutes/day
STANDARD_DEVIATION 41.7 • n=20 Participants • Data were not available for 5 participants.
96.7 minutes/day
STANDARD_DEVIATION 46.5 • n=40 Participants • Data were not available for 5 participants.
Ghrelin
870.3 pg/mL
STANDARD_DEVIATION 341.5 • n=21 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 2 participants who started phase 1 in sleep restriction condition
750.5 pg/mL
STANDARD_DEVIATION 251 • n=21 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 2 participants who started phase 1 in sleep restriction condition
810.4 pg/mL
STANDARD_DEVIATION 302.1 • n=42 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 2 participants who started phase 1 in sleep restriction condition
Leptin
21.9 ng/mL
STANDARD_DEVIATION 19.3 • n=21 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
26.5 ng/mL
STANDARD_DEVIATION 19.9 • n=22 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
24.3 ng/mL
STANDARD_DEVIATION 19.5 • n=43 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
Glucagon-like peptide 1
25.0 pM
STANDARD_DEVIATION 13.1 • n=21 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
21.5 pM
STANDARD_DEVIATION 11.0 • n=22 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
23.2 pM
STANDARD_DEVIATION 12.1 • n=43 Participants • Blood samples were not available at baseline for 1 participant who started phase 1 in adequate sleep condition and 1 participant who started phase 1 in sleep restriction condition
Orexin
1.34 ng/mL
STANDARD_DEVIATION 0.52 • n=15 Participants • Assay was run on a sub-set of participants
1.21 ng/mL
STANDARD_DEVIATION 0.48 • n=17 Participants • Assay was run on a sub-set of participants
1.28 ng/mL
STANDARD_DEVIATION 0.5 • n=32 Participants • Assay was run on a sub-set of participants
Neuropeptide Y
1.37 ng/mL
STANDARD_DEVIATION 0.68 • n=15 Participants • Assay was run on a subset of participants
1.32 ng/mL
STANDARD_DEVIATION 0.68 • n=17 Participants • Assay was run on a subset of participants
1.34 ng/mL
STANDARD_DEVIATION 0.67 • n=32 Participants • Assay was run on a subset of participants

PRIMARY outcome

Timeframe: Week 6 (endpoint)

Population: Data were available from 38 women who underwent MRI scanning for body composition assessment.

Body composition (specifically fat volume) will be measured by MRI at baseline and endpoint.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=38 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=38 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Endpoint Fat Volume
24.0 Liter
Standard Deviation 11.4
24.2 Liter
Standard Deviation 11.6

SECONDARY outcome

Timeframe: Measured over 14 days at the end of each phase (weeks 5 and 6; endpoint)

EE is the amount of energy (or calories) that a person needs to carry out physical functions and will be assessed using Doubly Labeled Water (DLW), during the last 2 weeks of each sleep phase.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=32 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=30 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Energy Expenditure (EE)
2445 kcal/d
Standard Deviation 548
2476 kcal/d
Standard Deviation 527

SECONDARY outcome

Timeframe: Average over 6 weeks (measured daily)

Time spent in moderate-to-vigorous physical activity.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=39 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=39 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Physical Activity
86.1 minutes/day
Standard Deviation 48.1
87.4 minutes/day
Standard Deviation 43.4

SECONDARY outcome

Timeframe: 6 weeks

Average post-baseline values

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=41 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=37 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Ghrelin
856.6 pg/mL
Standard Deviation 325.7
819.4 pg/mL
Standard Deviation 287.2

SECONDARY outcome

Timeframe: Week 6

Population: fMRI data was collected from 26 participants.

The primary aim of this outcome was to investigate brain activation in response to food stimuli after a six-week period of Adequate Sleep (AS) or mild Sleep Restriction (SR). To achieve this, the investigators contrasted neuronal responses to food and non-food stimuli at two time points (baseline and six weeks post-intervention/control). This contrast allowed the investigators to calculate the number of voxels activated during the view of food stimuli compared to the number of voxels activated during the view of non-food stimuli (food - non-food) under each condition (AS or SR). Regional brain activation is reported as the total number of voxels activated on the group contrast images (combination of all analyzed participants) of the neuronal response to food stimuli compared to non-food stimuli. For this analysis, voxels were considered activated if they survived Gaussian Random Field theory correction with a 2-tailed p \< 0.001 threshold when creating the group contrast images.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=26 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=26 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Regional Brain Activation in Response to Food Stimuli
469 Activated Voxels
218 Activated Voxels

SECONDARY outcome

Timeframe: Average over 6 weeks (measured daily)

Time spent in sedentary physical activity.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=39 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=39 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Sedentary Behavior
766.9 minutes/day
Standard Deviation 106.5
851 minutes/day
Standard Deviation 87.6

SECONDARY outcome

Timeframe: 6 weeks

Average post-baseline values

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=41 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=37 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Leptin
23.4 ng/mL
Standard Deviation 18.9
23.5 ng/mL
Standard Deviation 19.2

SECONDARY outcome

Timeframe: 6 weeks

Average post-baseline values

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=42 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=37 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Glucagon-like Peptide 1
22.9 pM
Standard Deviation 9.7
23.0 pM
Standard Deviation 11.1

SECONDARY outcome

Timeframe: 6 weeks

Population: Assays were run on a sub-set of participants.

Average post-baseline values

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=30 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=30 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Orexin
1.29 ng/mL
Standard Deviation 0.61
1.34 ng/mL
Standard Deviation 0.62

SECONDARY outcome

Timeframe: 6 weeks

Population: Assay run on a sub-set of participants

Average post-baseline values

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=29 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=29 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Neuropeptide Y
1.36 ng/mL
Standard Deviation 0.70
1.41 ng/mL
Standard Deviation 0.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 6 (endpoint)

Working memory data were collected using the List Sorting Working Memory Test from the NIH Toolbox. Data were transformed into a t-score ranging from 0-100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data were collected at baseline and after 6 weeks on study intervention. Traditionally, a clinically relevant threshold for cognitive data is 1.5 standard deviations below the mean. For a t-score, this would mean that a score of 35 or lower suggests clinical relevance.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=12 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=10 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
NIH Toolbox®
57.2 T-score
Standard Deviation 6.5
50.8 T-score
Standard Deviation 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 6 (endpoint)

Episodic verbal learning and memory were collected using the Modified Rey Auditory Verbal Learning Test (ModRey). The primary variable of interest for this test is the number of correctly recalled words across three learning trials from List A consisting of 20 words in each trial. The total score range across three trials is 0-60. A higher score indicates better performance.

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=15 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=13 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Neuro-behavioral Measures
33.8 score
Standard Deviation 8.7
33.5 score
Standard Deviation 9.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 5 (endpoint)

CD8+ T-cells from samples collected late in the day (non-fasted)

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=11 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=13 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Immune Function
102212 cells/mL
Standard Deviation 88785
107844 cells/mL
Standard Deviation 259554

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 5 (endpoint)

Classical monocytes measured from samples collected late in the day (non-fasted)

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=11 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=13 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Immune Markers
80038 cells/mL
Standard Deviation 41470
134056 cells/mL
Standard Deviation 59315

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 5

Distance walked over a 6-minute walk test

Outcome measures

Outcome measures
Measure
Habitual Sleep (HS)
n=28 Participants
Participants will be asked to follow a fixed bedtime routine based on the participant's regular bed- and wake-times during the habitual sleep (HS) phase.
Sleep Restriction (SR)
n=29 Participants
Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time during the sleep restriction (SR) phase. Sleep Restriction (SR): Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
Distance Walked
620.2 meters
Standard Deviation 81.1
625.7 meters
Standard Deviation 85.2

Adverse Events

Habitual Sleep (HS)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sleep Restriction (SR)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie-Pierre St-Onge

Columbia University Irving Medical Center

Phone: 212-305-9379

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place