Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2004-08-31
Brief Summary
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Detailed Description
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Sleeping medication use is higher in older than younger adults, and is a risk factor for falls. Current evidence suggests that sleeping medications impair walking stability and cognitive performance in young and older adults during wakefulness; however, no study has examined walking stability and cognitive performance of young and older adults upon awakening from sleep at night after taking a hypnotic (sleeping medication). Therefore, the purpose of this study is to determine whether sleep inertia and hypnotic use impairs walking stability and cognitive performance more in healthy older than in healthy younger adults. It is expected that findings from the proposed study will provide evidence for sleep inertia as a risk factor for falls in older adults.
Twelve older (aged 60-85) and twelve younger (aged 18-35) healthy male and female volunteers will participate in the study. The investigational procedures will include medical screening (e.g., physical, blood and urine tests, and bone mineral density assessment), home monitoring of sleep schedules for three weeks, and three overnight visits in the laboratory spaced approximately one week apart. During the laboratory visits, participants will be awakened in the middle of the night to perform walking stability and cognitive function tests. Before going to bed, participants will take either a placebo pill or a sleeping medication. On one of the visits, participants will be asked to go to bed about 2 hours later than usual.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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zolpidem
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 35, or 60 to 85
* Lived at Denver altitude or higher for at least one year
* Stable treated diseases: thyroid dysfunction (including hypothyroidism and hyperthyroidism), hypertension, hypercholesterolemia, urinary incontinence, prostate enlargement, gastroesophageal reflux disease, irritable bowel syndrome
Exclusion Criteria
* BMI less than 18.6 or greater than 30 kg/m2, women below 95 pounds regardless of BMI
* Sleep duration is less than 5 or more than 9 hours
* Sensitivity to sleeping medications
* Night work in the preceding 6 months
* Transmeridian travel (across more than 2 time zones) in the last 1 month
* Bone mineral density DXA T-score of less than -1.75
* Orthostatic intolerance
* Prior history of falls in past year
* Prior history of injurious fall in past 5 years
* Hip fracture following a fall
* Difficulty rising from a sitting position without use of hands to push off
* Needing to walk slowly or with a wide base of support to maintain balance
* Hormone replacement therapy for less than 3 months
* Connective Tissue and Joint Disorders
* Neurologic Disorders
* Musculoskeletal Disorders
* Immune Disorders
* Sleep Disorders
* Chronobiologic Disorders
* Cardiovascular Disorders
* Respiratory Disorders
* Kidney and Urinary Tract Disorders
* Infectious Diseases
* Gastrointestinal Disorders
* Hematopoietic Disorders
* Neoplastic Diseases
* Endocrine and Metabolic Diseases
* Psychopathology
* Dementia
* Drug dependency
18 Years
85 Years
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
National Institute on Aging (NIA)
NIH
Principal Investigators
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Kenneth P. Wright, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Integrative Physiology, University of Colorado
Danielle J. Frey, PT, MS
Role: STUDY_DIRECTOR
Department of Integrative Physiology, University of Colorado
Locations
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University of Colorado at Boulder
Boulder, Colorado, United States
Countries
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References
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Brassington GS, King AC, Bliwise DL. Sleep problems as a risk factor for falls in a sample of community-dwelling adults aged 64-99 years. J Am Geriatr Soc. 2000 Oct;48(10):1234-40. doi: 10.1111/j.1532-5415.2000.tb02596.x.
Luukinen H, Koski K, Honkanen R, Kivela SL. Incidence of injury-causing falls among older adults by place of residence: a population-based study. J Am Geriatr Soc. 1995 Aug;43(8):871-6. doi: 10.1111/j.1532-5415.1995.tb05529.x.
Wertz AT, Ronda JM, Czeisler CA, Wright KP Jr. Effects of sleep inertia on cognition. JAMA. 2006 Jan 11;295(2):163-4. doi: 10.1001/jama.295.2.163. No abstract available.
Frey DJ, Ortega JD, Wiseman C, Farley CT, Wright KP Jr. Influence of zolpidem and sleep inertia on balance and cognition during nighttime awakening: a randomized placebo-controlled trial. J Am Geriatr Soc. 2011 Jan;59(1):73-81. doi: 10.1111/j.1532-5415.2010.03229.x.
Other Identifiers
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