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Chronic Moderate Sleep Restriction in Older Adults (MSSS)

Primary Purpose

Sleep Disturbance, Aging

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sleep restriction
Non-sleep restriction
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Disturbance focused on measuring Sleep disturbance, Aging, Sleep restriction, Health status, Glucose tolerance, Inflammation

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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

Sites / Locations

  • University of Arizona
  • UCLA Cousins Center for Psychoneuroimmunology
  • SUNY Downstate Medical Center
  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Non-sleep restriction

Sleep restriction

Arm Description

Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline

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.

Outcomes

Primary Outcome Measures

Change in adherence to sleep restriction from baseline
Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks

Secondary Outcome Measures

Change in sleepiness from baseline
Evaluation of sleepiness by weekly self-report for 12 weeks
Change in health functioning from baseline
Evaluation of health functioning by self-report for 12 weeks
Change in sleep quality from baseline
Evaluation of sleep quality by self report 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
Change in physical activity from baseline
Evaluation of physical activity by waist actigraphy and self-report 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
Change in depressive symptoms from baseline
Evaluation of depressive symptoms by self-report every 2 weeks for 12 weeks
Markers of inflammation
Evaluation of cellular and genomic markers of inflammation at baseline and at 12 weeks
Change in fatigue from baseline
Evaluation of fatigue by self-report every 2 weeks for 12 weeks

Full Information

First Posted
July 13, 2012
Last Updated
July 17, 2019
Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01642719
Brief Title
Chronic Moderate Sleep Restriction in Older Adults
Acronym
MSSS
Official Title
Chronic Moderate Sleep Restriction in Older Long Sleepers and Older Average Sleepers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Aging
Keywords
Sleep disturbance, Aging, Sleep restriction, Health status, Glucose tolerance, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-sleep restriction
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline
Arm Title
Sleep restriction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep restriction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-sleep restriction
Intervention Description
Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline.
Primary Outcome Measure Information:
Title
Change in adherence to sleep restriction from baseline
Description
Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks
Time Frame
Daily for 12 weeks
Secondary Outcome Measure Information:
Title
Change in sleepiness from baseline
Description
Evaluation of sleepiness by weekly self-report for 12 weeks
Time Frame
Every week for 12 weeks
Title
Change in health functioning from baseline
Description
Evaluation of health functioning by self-report for 12 weeks
Time Frame
Every 2 weeks for 12 weeks
Title
Change in sleep quality from baseline
Description
Evaluation of sleep quality by self report every month for 12 weeks
Time Frame
Every month for 12 weeks
Title
Change in measures of cognitive performance from baseline
Description
Evaluation of cognitive performance including standardized tasks to assess attention every month for 12 weeks
Time Frame
Every month for 12 weeks
Title
Change in physical activity from baseline
Description
Evaluation of physical activity by waist actigraphy and self-report every 8 weeks for 12 weeks
Time Frame
Every 8 weeks for 12 weeks
Title
Markers of glucose metabolism
Description
Evaluation of glucose metabolism by fasting glucose, glucose tolerance test, and hemoglobin A1C at baseline and again at 12 weeks
Time Frame
Baseline and at 12 weeks
Title
Change in depressive symptoms from baseline
Description
Evaluation of depressive symptoms by self-report every 2 weeks for 12 weeks
Time Frame
Every 2 weeks for 12 weeks
Title
Markers of inflammation
Description
Evaluation of cellular and genomic markers of inflammation at baseline and at 12 weeks
Time Frame
Baseline and at 12 weeks
Title
Change in fatigue from baseline
Description
Evaluation of fatigue by self-report every 2 weeks for 12 weeks
Time Frame
Every 2 weeks for 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn Yougstedt, Ph.d.
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Bootzin, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Irwin, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giardin Jean-Louis, Ph.D.
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721-0000
Country
United States
Facility Name
UCLA Cousins Center for Psychoneuroimmunology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
12201-0009
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208-0000
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.semel.ucla.edu/cousins
Description
UCLA Cousins Center for Psychoneuroimmunology

Learn more about this trial

Chronic Moderate Sleep Restriction in Older Adults

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