Homeostatic Sleep Regulation in Older Persons | NCT00601445

Studies
Homeostatic Sleep Regulation in Older Persons

NCT00601445

Sponsor

National Institute on Aging (NIA)

Status

Completed

Last Update Posted

May 30, 2008Estimated

Enrollment

58Estimated

Phase

Not Applicable

Conditions

Healthy
Aging

Interventions

Amount of sleep and wake

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P01-AG009975 - Project 4
P01AG009975	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Not provided

Completion Date

Mar 2004Actual

First Submitted Date

Oct 24, 2007

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2008

Last Update Posted Date

May 30, 2008Estimated

Name	Class
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amount of sleep and wake	Behavioral	4 groups with different patterns of sleep and wake

Measure	Description	Time Frame
Total Sleep Time		During inpatient study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-30 and 60-85 years
Healthy

Exclusion Criteria:

Any medications
Sleep Disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth B Klerman, MD, PhD	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States