Trial Outcomes & Findings for NM Balance Regulation With ULLS and Loss of Sleep (NCT NCT05956964)
NCT ID: NCT05956964
Last Updated: 2026-06-17
Results Overview
Subjects will sit upright in an isokinetic dynamometer with the knee at 60° flexion. Gel electrode pads will be placed over the femoral nerve and just proximal to the patellar tendon. Square wave, constant current, doublet pulses from an electrical stimulator will be used to evoke twitches prior to, during, and following a maximal voluntary isometric contraction (MVIC). Twitch torque will be measured in Newton-meters (Nm). Outcome data are reported as the percentage change in voluntary activation from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline and study completion, approximately 14 days
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Sleep Restriction (SR)
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Sleep Restriction (SR)
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
NM Balance Regulation With ULLS and Loss of Sleep
Baseline characteristics by cohort
| Measure |
Sleep Restriction (SR)
n=7 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
n=9 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 Year
STANDARD_DEVIATION 8.2 • n=9 Participants
|
26.7 Year
STANDARD_DEVIATION 10.7 • n=27 Participants
|
29.4 Year
STANDARD_DEVIATION 9.4 • n=267 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline and study completion, approximately 14 daysSubjects will sit upright in an isokinetic dynamometer with the knee at 60° flexion. Gel electrode pads will be placed over the femoral nerve and just proximal to the patellar tendon. Square wave, constant current, doublet pulses from an electrical stimulator will be used to evoke twitches prior to, during, and following a maximal voluntary isometric contraction (MVIC). Twitch torque will be measured in Newton-meters (Nm). Outcome data are reported as the percentage change in voluntary activation from baseline.
Outcome measures
| Measure |
Sleep Restriction (SR)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
n=7 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Change in Percentage in Interpolated Twitch Torque of the Loaded and Unloaded Leg
Unloaded Limb
|
-3.9 Percent change in voluntary activation
Standard Deviation 8.6
|
-12.5 Percent change in voluntary activation
Standard Deviation 16.5
|
|
Change in Percentage in Interpolated Twitch Torque of the Loaded and Unloaded Leg
Loaded Limb
|
2.6 Percent change in voluntary activation
Standard Deviation 5.9
|
1.5 Percent change in voluntary activation
Standard Deviation 15.9
|
PRIMARY outcome
Timeframe: Baseline and study completion, approximately 14 daysPopulation: Data unavailable for one subject.
Balance will be assessed using a dual force plate system. Participants will be asked to stand on one leg and maintain their balance for 15 seconds. Specific outcome measures include percentage change in center of pressure 95% ellipse area (sq. mm) compared to baseline.
Outcome measures
| Measure |
Sleep Restriction (SR)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Percent Change in Single Leg Stand (SLS)
Unloaded Limb
|
200 Percent change in COP ellipse area
Standard Deviation 181
|
250 Percent change in COP ellipse area
Standard Deviation 450
|
|
Percent Change in Single Leg Stand (SLS)
Loaded Limb
|
-24 Percent change in COP ellipse area
Standard Deviation 72
|
-43 Percent change in COP ellipse area
Standard Deviation 38
|
PRIMARY outcome
Timeframe: Post-intervention, approximately 14 days after start of studyDiffusion Tensor Imaging (DTI) will be used to quantify muscle volume of the loaded and unloaded leg. Subjects will lay supine, and slightly flex the knee (\~10°) to elongate and straighten the quadriceps. A spine array coil will be placed on the MR-scanner table and a flexible body coil wrapped around the upper thigh and centered over mid-thigh of the dominant leg. Multiple images will be taken. DSI Studio program will be used to analyze raw images.
Outcome measures
| Measure |
Sleep Restriction (SR)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
n=7 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Muscle Volume
Unloaded Limb
|
65.5 Centimeters cubed
Standard Deviation 11.9
|
72.4 Centimeters cubed
Standard Deviation 14.8
|
|
Muscle Volume
Loaded Limb
|
68.1 Centimeters cubed
Standard Deviation 11.9
|
77.3 Centimeters cubed
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Baseline and study completion, approximately 14 daysBalance will be assessed using a dual force plate system. Participants will stand on one leg on a stable force deck for 15 seconds. The mean Center of Pressure (CoP) velocity will be measured in millimeters per second (mm/s) for loaded and unloaded limbs. Outcomes are reported as the percentage change in mean velocity compared to pre-intervention.
Outcome measures
| Measure |
Sleep Restriction (SR)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.
|
Sleep Adequate (SA)
n=6 Participants
The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.
|
|---|---|---|
|
Percent Change in Center of Pressure Velocity During Single Leg Stance
Unloaded Limb
|
109 Percent change
Standard Deviation 29
|
43 Percent change
Standard Deviation 67
|
|
Percent Change in Center of Pressure Velocity During Single Leg Stance
Loaded Limb
|
-30 Percent change
Standard Deviation 59
|
-37 Percent change
Standard Deviation 42
|
Adverse Events
Sleep Restriction (SR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Adequate (SA)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place