Sleep DisturbancePhase 1MSSSNCT01642719
Chronic Moderate Sleep Restriction in Older Adults
A Phase 1 study testing Sleep restriction and Non-sleep restriction in people with Sleep Disturbance and Aging, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long sleepers (> 8 hr/night), but there has been little experimental investigation of the effects of chronic, moderate sleep loss in long or average sleepers. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Aging
- What is being tested?
- Sleep restriction and Non-sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2012to Dec 2018
- Phase
- Phase 1
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-80 years of age
- Sleeping an average of 8-9 hr per night for long sleeper (or)
- Sleep an average of 6.0-7.25 hr per night for short sleepers
- Able to designate a study partner that can speak on their behalf throughout the course of the study.
Who cannot join
- Reported average sleep duration of < 8.0 hr or > 9.0 hr for longer sleepers
- Reported average sleep duration of < 6 hr or > 7.25 hr for the average sleepers
- Spending > 30 min time in bed in the morning and/or night outside of the major sleep period (e.g., watching tv)
- Expected change in usual sleep duration in the near future (e.g., change in work schedule)
- Reported average napping of > 2 naps/day or total nap duration of > 90 min/day;
- Recent shift-work (previous 2 months) or travel across multiple time zones (previous 4 weeks), or plans for performing shift-work or transmeridian travel during the study time period;
Show all 15Show fewer
- Severe sleep apnea (apnea-hyponea index of greater or equal 15);
- Obesity (body mass index ≥35);
- High daytime sleepiness (Epworth Sleepiness Scale ≥ 10);
- Depression (Quick Inventory of Depressive Sympotomology > or equal to 16);
- Use of hypnotics or other drugs prescribed to promote sleep;
- Alcohol dependence or drug use;
- Any medical, neurologic, or psychiatric illness causing long sleep;
- Factors associated with significant changes in inflammation, including several medical disorders (e.g., rheumatoid arthritis), medications (e.g., steroids) and current smoking;
- Any health or mental condition that would contraindicate participation in the rigors of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SUNY Downstate Medical Center
Brooklyn, New York, 12201-0009
University of South Carolina
Columbia, South Carolina, 29208-0000
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, 90095
University of Arizona
Tucson, Arizona, 85721-0000
About this study
Official title: Chronic Moderate Sleep Restriction in Older Long Sleepers and Older Average Sleepers
Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long sleepers (> 8 hr/night), but there has been little experimental investigation of the effects of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that older adults might be particularly vulnerable to negative effects of sleep loss, whereas other scientists argue that many older adults spend too much time in bed, and that moderate reduction of time-in-bed could help increase the quality of their sleep, and could even promote health and longevity, particularly in long sleepers. At 4 sites across the US, we will conduct a large (200 people), randomized, controlled, 5- year study to examine whether a 1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on multiple health-related outcomes, including inflammation, sleepiness, body weight, mood, glucose regulation, quality of life, incidence of illness, and incidence of automobile accidents in older long sleepers as compared to older average sleepers.
Read the detailed description
Epidemiologic studies have consistently shown that self -reported sleep durations of <7 hr and >8 hr are associated with increased mortality and morbidity. The risks associated with short sleep are consistent with a vast experimental literature indicating detrimental effects of profound sleep restriction. However, there has been little study of chronic moderate sleep restriction, which is far more common, and thus more important from a public health standpoint. The risks associated with long sleep have scarcely been experimentally examined, though epidemiological data suggest sleep restriction might promote health/longevity in long sleepers. Older adults might be more vulnerable than young adults to negative effects of further sleep impairment, perhaps particularly via inflammatory mechanisms. Negative effects might be at least as evident in long sleepers as in average sleepers if long sleep reflects underlying morbidity, as many have posited. On the other hand, older adults might tolerate (or benefit) from moderate sleep restriction. Older adults often tend to spend excessive time in bed (TIB), particularly long sleepers, and extra TIB could contribute to age-related sleep fragmentation and morbidity, which could be ameliorated with modest TIB restriction. The aims of this study are: (1) to examine the ability of older long sleepers and older average sleepers to adhere to 60 min TIB restriction; and (2) to contrast effects of 12 weeks of 60 min TIB restriction on health-related measures in older long vs. average sleepers. One hundred older adults (ages 60-80 yr) who report sleeping 8-9 hr per night and 100 adults of the same age range who report sleeping 6-7.25 hr per night will be examined at 4 experimental sites over 5 years. Following a 2-week baseline, participants will be randomly assigned to one of two 12-week treatment groups. (1) A sleep restriction group (n=60 long sleepers and n=60 average sleepers) will be assigned to a fixed sleep- wake schedule, in which time in bed is reduced precisely 60 min below each participant's baseline time in bed (TIB). (2) A control group (n=40 long sleepers and n=40 average sleepers) will have no sleep restriction, but will also follow a fixed sleep schedule. Sleep will be assessed continuously with actigraphy and a daily diary. Questionnaires will be answered. Measures will include body weight, glucose tolerance, sleepiness, depression, quality of life, psychomotor vigilance, incidence of automobile accidents, incidence of illness, and multiple markers of inflammation. Physical exams during weeks 2 and 6 of the intervention and a study ombudsman will further monitor potential adverse effects. Follow-up assessments will be conducted for 12 months. The proposed clinical trial will provide the most comprehensive Phase 1 assessment of risks and benefits of chronic moderate TIB restriction ever conducted.
- Conditions
- Sleep Disturbance, Aging
- Being tested
- Sleep restriction, Non-sleep restriction
- Keywords
- Sleep disturbance, Aging, Sleep restriction, Health status, Glucose tolerance, Inflammation
- Medical subject headings
- Parasomnias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Participants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks.
Non-sleep restrictionBehavioural
Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline.
| Study group | Role | What they receive |
|---|---|---|
| Non-sleep restriction | Placebo comparator | Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline Receives: Behavioral: Non-sleep restriction |
| Sleep restriction | Experimental | Participants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks. For example, if they spend 9 hr TIB during baseline, they will reduce their TIB to 8 hr. Receives: Behavioral: Sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to sleep restriction from baseline
Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks
Measured: Daily for 12 weeks
Secondary outcomes (9)
Change in sleepiness from baseline
Evaluation of sleepiness by weekly self-report for 12 weeks
Measured: Every week for 12 weeks
Change in health functioning from baseline
Evaluation of health functioning by self-report for 12 weeks
Measured: Every 2 weeks for 12 weeks
Change in sleep quality from baseline
Evaluation of sleep quality by self report every month for 12 weeks
Measured: Every month for 12 weeks
Change in measures of cognitive performance from baseline
Evaluation of cognitive performance including standardized tasks to assess attention every month for 12 weeks
Measured: Every month for 12 weeks
Change in physical activity from baseline
Evaluation of physical activity by waist actigraphy and self-report every 8 weeks for 12 weeks
Measured: Every 8 weeks for 12 weeks
Markers of glucose metabolism
Evaluation of glucose metabolism by fasting glucose, glucose tolerance test, and hemoglobin A1C at baseline and again at 12 weeks
Measured: Baseline and at 12 weeks
Change in depressive symptoms from baseline
Evaluation of depressive symptoms by self-report every 2 weeks for 12 weeks
Measured: Every 2 weeks for 12 weeks
Markers of inflammation
Evaluation of cellular and genomic markers of inflammation at baseline and at 12 weeks
Measured: Baseline and at 12 weeks
Change in fatigue from baseline
Evaluation of fatigue by self-report every 2 weeks for 12 weeks
Measured: Every 2 weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start1 Jul 2012
- Primary completion1 Aug 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michael Irwin, MD, University of California, Los Angeles
- Investigators
- Shawn Yougstedt, Ph.d., Principal investigator, University of South CarolinaRichard Bootzin, Ph.D., Principal investigator, University of ArizonaMichael Irwin, M.D., Principal investigator, University of California, Los AngelesGiardin Jean-Louis, Ph.D., Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642719
- Sponsor's protocol ID
- 1R01HL095799-01A2
- Other IDs
- 1R01HL095799-01A2
- Acronym
- MSSS
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2012
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Moderate Sleep Restriction in Older Long Sleepers and Older Average Sleepers
- ClinicalTrials.gov ID
- NCT01642719
- Acronym / sponsor ID
- MSSS / 1R01HL095799-01A2
- Conditions
- Sleep Disturbance, Aging
- Keywords
- Sleep disturbance, Aging, Sleep restriction, Health status, Glucose tolerance, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 17 Jul 2012 (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.
Higher rates of mortality have been found both in short sleepers (< 6 hr/night) and long sleepers (> 8 hr/night), but there has been little experimental investigation of the effects of chronic, moderate sleep loss in long or average sleepers. Some scientists argue that older adults might be particularly vulnerable to negative effects of sleep loss, whereas other scientists argue that many older adults spend too much time in bed, and that moderate reduction of time-in-bed could help increase the quality of their sleep, and could even promote health and longevity, particularly in long sleepers. At 4 sites across the US, we will conduct a large (200 people), randomized, controlled, 5- year study to examine whether a 1-hour reduction of time spent in bed for 12 weeks has negative or positive effects on multiple health-related outcomes, including inflammation, sleepiness, body weight, mood, glucose regulation, quality of life, incidence of illness, and incidence of automobile accidents in older long sleepers as compared to older average sleepers.
Detailed description
Epidemiologic studies have consistently shown that self -reported sleep durations of <7 hr and >8 hr are associated with increased mortality and morbidity. The risks associated with short sleep are consistent with a vast experimental literature indicating detrimental effects of profound sleep restriction. However, there has been little study of chronic moderate sleep restriction, which is far more common, and thus more important from a public health standpoint. The risks associated with long sleep have scarcely been experimentally examined, though epidemiological data suggest sleep restriction might promote health/longevity in long sleepers. Older adults might be more vulnerable than young adults to negative effects of further sleep impairment, perhaps particularly via inflammatory mechanisms. Negative effects might be at least as evident in long sleepers as in average sleepers if long sleep reflects underlying morbidity, as many have posited. On the other hand, older adults might tolerate (or benefit) from moderate sleep restriction. Older adults often tend to spend excessive time in bed (TIB), particularly long sleepers, and extra TIB could contribute to age-related sleep fragmentation and morbidity, which could be ameliorated with modest TIB restriction. The aims of this study are: (1) to examine the ability of older long sleepers and older average sleepers to adhere to 60 min TIB restriction; and (2) to contrast effects of 12 weeks of 60 min TIB restriction on health-related measures in older long vs. average sleepers. One hundred older adults (ages 60-80 yr) who report sleeping 8-9 hr per night and 100 adults of the same age range who report sleeping 6-7.25 hr per night will be examined at 4 experimental sites over 5 years. Following a 2-week baseline, participants will be randomly assigned to one of two 12-week treatment groups. (1) A sleep restriction group (n=60 long sleepers and n=60 average sleepers) will be assigned to a fixed sleep- wake schedule, in which time in bed is reduced precisely 60 min below each participant's baseline time in bed (TIB). (2) A control group (n=40 long sleepers and n=40 average sleepers) will have no sleep restriction, but will also follow a fixed sleep schedule. Sleep will be assessed continuously with actigraphy and a daily diary. Questionnaires will be answered. Measures will include body weight, glucose tolerance, sleepiness, depression, quality of life, psychomotor vigilance, incidence of automobile accidents, incidence of illness, and multiple markers of inflammation. Physical exams during weeks 2 and 6 of the intervention and a study ombudsman will further monitor potential adverse effects. Follow-up assessments will be conducted for 12 months. The proposed clinical trial will provide the most comprehensive Phase 1 assessment of risks and benefits of chronic moderate TIB restriction ever conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-sleep restriction | Placebo comparator | Behavioral: Non-sleep restrictionParticipants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline |
| Sleep restriction | Experimental | Behavioral: Sleep restrictionParticipants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks. For example, if they spend 9 hr TIB during baseline, they will reduce their TIB to 8 hr. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60-80 years of age
- Sleeping an average of 8-9 hr per night for long sleeper (or)
- Sleep an average of 6.0-7.25 hr per night for short sleepers
- Able to designate a study partner that can speak on their behalf throughout the course of the study.
Key exclusion criteria (15 listed)
- Reported average sleep duration of < 8.0 hr or > 9.0 hr for longer sleepers
- Reported average sleep duration of < 6 hr or > 7.25 hr for the average sleepers
- Spending > 30 min time in bed in the morning and/or night outside of the major sleep period (e.g., watching tv)
- Expected change in usual sleep duration in the near future (e.g., change in work schedule)
- Reported average napping of > 2 naps/day or total nap duration of > 90 min/day;
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 |
|---|---|---|
| Sleep restrictionParticipants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks. | Behavioural | Sleep restriction |
| Non-sleep restrictionParticipants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline. | Behavioural | Non-sleep restriction |
Primary outcome
Change in adherence to sleep restriction from baseline
Time frame: Daily for 12 weeks
Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks
9 secondary outcomes
Change in sleepiness from baseline
Time frame: Every week for 12 weeks
Change in health functioning from baseline
Time frame: Every 2 weeks for 12 weeks
Change in sleep quality from baseline
Time frame: Every month for 12 weeks
Change in measures of cognitive performance from baseline
Time frame: Every month for 12 weeks
Change in physical activity from baseline
Time frame: Every 8 weeks for 12 weeks
Markers of glucose metabolism
Time frame: Baseline and at 12 weeks
Change in depressive symptoms from baseline
Time frame: Every 2 weeks for 12 weeks
Markers of inflammation
Time frame: Baseline and at 12 weeks
Change in fatigue from baseline
Time frame: Every 2 weeks for 12 weeks
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 18 Jul 2019.
- UCLA Cousins Center for PsychoneuroimmunologyLink provided by the sponsor.
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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.
Shawn Yougstedt, Ph.d. principal investigator
University of South Carolina
Richard Bootzin, Ph.D. principal investigator
University of Arizona
Michael Irwin, M.D. principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sleep restriction and Non-sleep restriction in people with Sleep Disturbance and Aging, run by University of California, Los Angeles at 4 sites 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 4 inclusion and 15 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in adherence to sleep restriction from baseline (time frame: Daily for 12 weeks). 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 18 Jul 2019.