SleepAgeWiseNCT00177385
Aging Well, Sleeping Efficiently: Protecting Health In Later Life
A study testing Modest sleep deprivation with sleep hygiene education in people with Sleep and Health Promotion, run by University of Pittsburgh.
Trial summary
The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Health Promotion
- What is being tested?
- Modest sleep deprivation with sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Sep 2011
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 75 or older
- without sleep disorders
- without psychiatric disorders
- Folstein MMSE of 24 or greater
Who cannot join
- Apnea-hypopnea index greater than 30
- Mean sleep latency less than 6
- Psychotropic medications present
About this study
Official title: AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE
The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.
Read the detailed description
The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.
- Conditions
- Sleep, Health Promotion
- Being tested
- Modest sleep deprivation with sleep hygiene education
- Keywords
- Sleep, Sleep Hygiene, Modest sleep deprivation, Healthy Aging and sleep, Health Promotion
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modest sleep deprivation with sleep hygiene educationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.
Secondary outcomes (1)
Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Charles F. Reynolds lll, M.D., Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177385
- Sponsor's protocol ID
- IRB #021116
- Other IDs
- 5P01AG020677, 5P01AG020677-05
- Acronym
- AgeWise
- Status last verified
- May 2015
- First submitted
- 12 Sep 2005
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE
- ClinicalTrials.gov ID
- NCT00177385
- Acronym / sponsor ID
- AgeWise / IRB #021116
- Conditions
- Sleep, Health Promotion
- Keywords
- Sleep, Sleep Hygiene, Modest sleep deprivation, Healthy Aging and sleep, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Sep 2005 (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 see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.
Detailed description
The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age 75 or older
- without sleep disorders
- without psychiatric disorders
- Folstein MMSE of 24 or greater
Key exclusion criteria (3 listed)
- Apnea-hypopnea index greater than 30
- Mean sleep latency less than 6
- Psychotropic medications present
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 |
|---|---|---|
| Modest sleep deprivation with sleep hygiene education | Behavioural | – |
Primary outcome
Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.
1 secondary outcome
Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons.
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 28 May 2015.
- AgeWise Program DescriptionLink provided by the sponsor.
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Healthy Adult Participants
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.
Charles F. Reynolds lll, M.D. principal investigator
University of Pittsburgh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Modest sleep deprivation with sleep hygiene education in people with Sleep and Health Promotion, run by University of Pittsburgh.
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 4 inclusion and 3 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons.. 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 28 May 2015.