NCT00817700

Brief Summary

This project has 6 aims.

  1. 1.To examine the impact of recurrent partial sleep loss in young, middle-aged and older men and women. Sleep will be restricted to 4 hours.
  2. 2.To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep restriction.
  3. 3.To test the hypothesis that there are age and gender differences in the total amount of sleep recovery obtained during the week of 12-hour bedtimes.
  4. 4.To test the hypothesis that there are age and gender differences in sleep capacity (the amount of time an individual can sleep per night when there is no sleep debt).
  5. 5.To test the hypothesis that sleep capacity is partly determined by baseline levels of slow-wave sleep and slow-wave activity.
  6. 6.To determine whether sleep capacity is related to sleep need by examining metabolic, endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual sleep debt.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 5, 2009

Last Update Submit

January 9, 2017

Conditions

Keywords

Sleepyoung adultsmiddle-age adultsolder adults

Outcome Measures

Primary Outcomes (1)

  • Endocrine, metabolic, cardiovascular changes performance and autonomic nervous system activity before and after sleep restriction and after sleep recovery.

    Completion of 23 day study

Study Arms (2)

Normal (8 hours) sleep time

NO INTERVENTION

Subjects are studied under normal sleep time conditions.

Sleep restriction

EXPERIMENTAL

Sleep restriction to 4 hours of sleep per night. Overnight sleep recording, measures of endocrine and metabolic (from blood), cardiovascular (measures of blood pressure and heart rate), performance ( before and after sleep restriction and after sleep recovery.

Other: Sleep restriction

Interventions

Sleep restriction.

Sleep restriction

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal weight
  • healthy
  • age 18-75 old

You may not qualify if:

  • sleep disorder
  • irregular life habits (shift workers, travelers)
  • smokers
  • on medication
  • consumption of \> 2 alcohol or caffeinated beverages/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Eve Van Cauter, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

April 1, 2005

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations