Chronic Moderate Sleep Restriction in Older Adults



Status:Recruiting
Conditions:Healthy Studies, Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:60 - 80
Updated:4/2/2016
Start Date:July 2012
End Date:July 2017

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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.

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.

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
We found this trial at
4
sites
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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Columbia, South Carolina 29208
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Columbia, SC
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Los Angeles, California 91744
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Los Angeles, CA
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