Sleepiness and the Risk of Falling

Aging Clinical Trial

Official title:

Aging, Hypnotics, Sleep Inertia and the Risk of Falling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383357
• Other study ID #: AG0070
• Secondary ID: 5R03AG024621-025
• Status: Completed
• Phase: N/A
• First received: September 28, 2006
• Last updated: September 19, 2007
• Start date: August 2004

Study information

• 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

Clinical Trial Summary

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.

Description:

Awakening from sleep is well documented to impair cognitive performance in young adults. This phenomenon, called sleep inertia, has been reported to impair performance just as much as one night of total sleep deprivation, suggesting that there are significant functional consequences to sleep inertia. However, whether walking stability is impaired by sleep inertia is unknown. If sleep inertia impairs walking stability, it could be an important but currently unrecognized risk factor for falls in older adults. Also, the impact of aging on sleep inertia-related impairments in cognitive performance is unknown.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Balance
• Sleep

Intervention

Drug:
• zolpidem

Locations

Country	Name	City	State
United States	University of Colorado at Boulder	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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.