- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00601445
Homeostatic Sleep Regulation in Older Persons
May 28, 2008 updated by: National Institute on Aging (NIA)
The purpose of this study is to test the hypothesis that sleep homeostasis, also known as sleep pressure or sleep drive, is different in healthy older and younger individuals.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This was an inpatient study of healthy individuals to determine whether homeostatic "sleep drive" effects on sleep change with healthy aging.
Sleep, performance, and mood were studied on individuals sleeping different lengths of time and during wake periods of different durations.
Study Type
Interventional
Enrollment (Anticipated)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-30 and 60-85 years
- Healthy
Exclusion Criteria:
- Any medications
- Sleep Disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total Sleep Time
Time Frame: During inpatient study
|
During inpatient study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elizabeth B Klerman, MD, PhD, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Study Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
October 24, 2007
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 28, 2008
Study Record Updates
Last Update Posted (Estimate)
May 30, 2008
Last Update Submitted That Met QC Criteria
May 28, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AG0090
- P01-AG009975 - Project 4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.