NCT00383357

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

September 28, 2006

Last Update Submit

September 19, 2007

Conditions

AgingBalanceSleep

Keywords

PerformanceGait stabilitysedativehypnoticquality of lifesleep disorderwakefulnesssleeping pillsCognitive function

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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.

Interventions

zolpidemDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (4)

  • 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.

    PMID: 11037010BACKGROUND

  • 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.

    PMID: 7636094BACKGROUND

  • 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.

    PMID: 16403927BACKGROUND

  • 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.

    PMID: 21226678DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kenneth P. Wright, PhD

    Department of Integrative Physiology, University of Colorado

    PRINCIPAL INVESTIGATOR

  • Danielle J. Frey, PT, MS

    Department of Integrative Physiology, University of Colorado

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 28, 2006

First Posted

October 3, 2006

Study Start

August 1, 2004

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

US(1)