Aging Clinical Trial
Official title:
Aging, Hypnotics, Sleep Inertia and the Risk of Falling
Verified date | September 2007 |
Source | National Institute on Aging (NIA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this project is to examine the impact of sleeping pills and waking up in the middle of the night on walking balance and cognitive function, to identify risk factors for falls in older adults. A significant percentage of falls, approximately 33 to 52 percent, occur during the nighttime and morning hours when people are normally sleeping; therefore, it is possible that sleep and sleeping medication related impairments in balance may contribute to this risk.
Status | Completed |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Males and females - 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: - Aged 36 to 59, under 18, or over 85 - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado at Boulder | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) | National Center for Research Resources (NCRR) |
United States,
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. — View Citation
Luukinen H, Koski K, Honkanen R, Kivelä 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. — View Citation
Wertz AT, Ronda JM, Czeisler CA, Wright KP Jr. Effects of sleep inertia on cognition. JAMA. 2006 Jan 11;295(2):163-4. Erratum in: JAMA. 2006 Feb 15;295(7):760. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in gait stability: normal walking and beam walking across force plates (platforms with sensors that measure the force (energy) that occurs when the foot contacts the ground during walking) | |||
Primary | at 1, 15, and 30 minutes after awakening in the middle of the night during all three visits | |||
Secondary | Changes in gait stability: normal walking and beam walking across force plates at 1, 15, and 30 minutes after awakening in the morning during all three visits. | |||
Secondary | cognitive performance: computerized assessment of executive function at 5, 20, and 35 minutes after awakening in the middle of the night and in the morning during all three visits. | |||
Secondary | sleep architecture: visual scoring of the sleep EEG across 8 hours of scheduled sleep during all three visits. |
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