Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01581125
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Sleep Deprivation; Insufficient Sleep Syndrome	Behavioral: Sleep:wake 1; Behavioral: Sleep:wake 2	N/A

Detailed Description

The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sleep:wake 2 Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1.	Behavioral: Sleep:wake 2; Sleep and Wake durations for arm2
Experimental: Sleep:wake 1 Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2.	Behavioral: Sleep:wake 1; Sleep and Wake durations for arm 1

Outcome Measures

Primary Outcome Measures

1. Psychomotor Vigilance Task (PVT) performance [PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol]

   PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

Exclusion Criteria:

• Prescription medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Elizabeth B Klerman, MD PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01581125
• Other Study ID Numbers: NIH R01 HL114088-01
• First Posted: Apr 19, 2012
• Last Update Posted: Jul 18, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital: Inpatients; Health Normalcy; circadian rhythm
• Additional relevant MeSH terms: Sleep Deprivation

Study Results

No Results Posted as of Jul 18, 2016