Trial Outcomes & Findings for Sleep Length and Circadian Regulation in Humans (NCT NCT00843843)

NCT ID: NCT00843843

Last Updated: 2016-03-08

Results Overview

Gold standard marker of circadian timing

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 12 days from baseline to final dim light melatonin onset
• Results posted on: 2016-03-08

Participant Flow

Participant milestones

Measure	9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days) 9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.	3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days) 3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
Overall Study STARTED	8	8
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days) 9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.	3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days) 3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	1	1

Baseline Characteristics

Sleep Length and Circadian Regulation in Humans

Baseline characteristics by cohort

Measure	9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep n=8 Participants Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.	3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap n=8 Participants Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.	Total n=16 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 9.0 • n=5 Participants	26.5 years STANDARD_DEVIATION 5.8 • n=7 Participants	28.5 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days from baseline to final dim light melatonin onset

Gold standard marker of circadian timing

Outcome measures

Measure	9 Hour Sleep n=12 Participants	3 Hour Nap and 6 Hour Sleep n=12 Participants
Dim Light Melatonin Onset (Hours)	1.93 hours Standard Deviation 0.98	0.80 hours Standard Deviation 0.92

SECONDARY outcome

Timeframe: after short or long nights

Population: Means

Fastest 10% reaction time (msec)

Outcome measures

Measure	9 Hour Sleep n=12 Participants	3 Hour Nap and 6 Hour Sleep n=12 Participants
Psychomotor Vigilance	215.15 msec Standard Deviation 32.57	221.16 msec Standard Deviation 33.56

Adverse Events

9 Hour Sleep

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 Hour Nap and 6 Hour Sleep

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

Dr. Helen Burgess

Rush University Medical Center

Phone: 3125634785

Email: Helen_J_Burgess@rush.edu

Results disclosure agreements

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