Trial Outcomes & Findings for Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction (NCT NCT02063217)
NCT ID: NCT02063217
Last Updated: 2018-04-26
Results Overview
Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00
Results posted on
2018-04-26
Participant Flow
Participant milestones
| Measure |
Sleep Induction
6.5-7.5 grams of sodium oxybate
Sodium Oxybate: Sodium oxybate h.s.
|
Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation: 36hr sleep deprivation
|
Control
Participant will sleep as normal under the same controlled conditions in a clinical research unit
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sleep Induction
6.5-7.5 grams of sodium oxybate
Sodium Oxybate: Sodium oxybate h.s.
|
Sleep Deprivation
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation: 36hr sleep deprivation
|
Control
Participant will sleep as normal under the same controlled conditions in a clinical research unit
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Baseline characteristics by cohort
| Measure |
Sleep Induction
n=11 Participants
6.5-7.5 grams of sodium oxybate
Sodium Oxybate: Sodium oxybate h.s.
|
Sleep Deprivation
n=12 Participants
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation: 36hr sleep deprivation
|
Control
n=12 Participants
Participant will sleep as normal under the same controlled conditions in a clinical research unit
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Continuous
|
45.5 years
n=99 Participants
|
42.0 years
n=107 Participants
|
42.7 years
n=206 Participants
|
43.3 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00Population: Participants in good general health who had CSF collected every 2 hours for 36 hours while undergoing with sleep deprivation, sleep induction with drug, or control conditions.
Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.
Outcome measures
| Measure |
Sleep Induction
n=11 Participants
6.5-7.5 grams of sodium oxybate
Sodium Oxybate: Sodium oxybate h.s.
|
Sleep Deprivation
n=12 Participants
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation: 36hr sleep deprivation
|
Control
n=12 Participants
Participant will sleep as normal under the same controlled conditions in a clinical research unit
|
|---|---|---|---|
|
Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline
|
113 percent increase from mean baseline
Standard Error 5.7
|
123 percent increase from mean baseline
Standard Error 6.6
|
106 percent increase from mean baseline
Standard Error 5.6
|
Adverse Events
Sleep Induction
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Sleep Deprivation
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sleep Induction
n=12 participants at risk
6.5-7.5 grams of sodium oxybate
Sodium Oxybate: Sodium oxybate h.s.
|
Sleep Deprivation
n=12 participants at risk
Sleep deprivation for up to 36 hours with no naps or other sleep periods
Sleep deprivation: 36hr sleep deprivation
|
Control
n=12 participants at risk
Participant will sleep as normal under the same controlled conditions in a clinical research unit
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
83.3%
10/12 • Number of events 10 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
66.7%
8/12 • Number of events 8 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
66.7%
8/12 • Number of events 8 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Nervous system disorders
Headache requiring blood patch
|
33.3%
4/12 • Number of events 4 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
33.3%
4/12 • Number of events 4 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • Number of events 5 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
33.3%
4/12 • Number of events 4 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 4 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
25.0%
3/12 • Number of events 3 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Cardiac disorders
Presyncope/syncope with lumbar catheter placement
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Nervous system disorders
Leg tingling
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Musculoskeletal and connective tissue disorders
Back/neck pain
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
25.0%
3/12 • Number of events 3 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
2/12 • Number of events 2 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
General disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
|
General disorders
Sweating
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
0.00%
0/12 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
8.3%
1/12 • Number of events 1 • Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.
|
Additional Information
Dr. Brendan Lucey
Washington University School of Medicine
Phone: 314-362-4342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place