HealthyNCT00601445
Homeostatic Sleep Regulation in Older Persons
A study testing Amount of sleep and wake in people with Healthy and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Amount of sleep and wake
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-30 and 60-85 years
- Healthy
Who cannot join
- Any medications
- Sleep Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Being tested
- Amount of sleep and wake
- Keywords
- Changes in sleep with aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amount of sleep and wakeBehavioural
4 groups with different patterns of sleep and wake
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Measured: During inpatient study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startSep 1999
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601445
- Sponsor's protocol ID
- AG0090
- Other IDs
- P01-AG009975 - Project 4, P01AG009975
- Status last verified
- May 2008
- First submitted
- 24 Oct 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeostatic Sleep Regulation in Older Persons
- ClinicalTrials.gov ID
- NCT00601445
- Acronym / sponsor ID
- AG0090
- Keywords
- Changes in sleep with aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Brigham and Women's Hospital
- Study start
- Sep 1999
- Study completion
- Mar 2004 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-30 and 60-85 years
- Healthy
Key exclusion criteria (2 listed)
- Any medications
- Sleep Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amount of sleep and wake4 groups with different patterns of sleep and wake | Behavioural | – |
Primary outcome
Total Sleep Time
Time frame: During inpatient study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth B Klerman, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amount of sleep and wake in people with Healthy and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: During inpatient study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.