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Sleepiness and the Risk of Falling

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ClinicalTrials.gov Identifier: NCT00383357
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : September 20, 2007
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE September 28, 2006
First Posted Date  ICMJE October 3, 2006
Last Update Posted Date September 20, 2007
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2006)
  • 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)
  • at 1, 15, and 30 minutes after awakening in the middle of the night during all three visits
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00383357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2006)
  • 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.
  • 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.
  • sleep architecture: visual scoring of the sleep EEG across 8 hours of scheduled sleep during all three visits.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleepiness and the Risk of Falling
Official Title  ICMJE Aging, Hypnotics, Sleep Inertia and the Risk of Falling
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Aging
  • Balance
  • Sleep
Intervention  ICMJE Drug: zolpidem
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 29, 2006)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00383357
Other Study ID Numbers  ICMJE AG0070
5R03AG024621-02 ( U.S. NIH Grant/Contract )
5M01RR000051-45 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Kenneth P. Wright, PhD Department of Integrative Physiology, University of Colorado
Study Director: Danielle J. Frey, PT, MS Department of Integrative Physiology, University of Colorado
PRS Account National Institute on Aging (NIA)
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP