Chronic Moderate Sleep Restriction in Older Adults

NCT01642719 | Completed Phase 1 DMC

• 1 other identifier: 1R01HL095799-01A2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep Disturbance; Aging

Keywords

Sleep disturbance; Aging; Sleep restriction; Health status; Glucose tolerance; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in adherence to sleep restriction from baseline

  Evaluation of ability to adhere to a 60 min time-in-bed restriction over 12 weeks

  Daily for 12 weeks

Secondary Outcomes (9)

• Change in sleepiness from baseline

  Every week for 12 weeks

• Change in health functioning from baseline

  Every 2 weeks for 12 weeks

• Change in sleep quality from baseline

  Every month for 12 weeks

• Change in measures of cognitive performance from baseline

  Every month for 12 weeks

• Change in physical activity from baseline

  Every 8 weeks for 12 weeks

Study Arms (2)

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

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.

Behavioral: Sleep restriction

Interventions

Sleep restriction BEHAVIORAL

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.

Sleep restriction

Non-sleep restriction BEHAVIORAL

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

Non-sleep restriction

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of Arizona

Tucson, Arizona, 85721-0000, United States

Location

UCLA Cousins Center for Psychoneuroimmunology

Los Angeles, California, 90095, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 12201-0009, United States

Location

University of South Carolina

Columbia, South Carolina, 29208-0000, United States

Location

Related Links

• UCLA Cousins Center for Psychoneuroimmunology

MeSH Terms

Conditions

Parasomnias; Inflammation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shawn Yougstedt, Ph.d.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

• Richard Bootzin, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Michael Irwin, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Giardin Jean-Louis, Ph.D.

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cousins Center for Psychoneuroimmunology; Cousins Professor,Department of Psychiatry

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (4)