AgingNCT00383357
Sleepiness and the Risk of Falling
A study testing zolpidem in people with Aging and Balance, run by National Institute on Aging (NIA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- zolpidem
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Boulder
Boulder, Colorado, 80309
About this study
Official title: Aging, Hypnotics, Sleep Inertia and the Risk of Falling
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.
Read the 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.
- Being tested
- zolpidem
- Keywords
- Performance, Gait stability, sedative, hypnotic, quality of life, sleep disorder, wakefulness, sleeping pills, Cognitive function
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolpidemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Kenneth P. Wright, PhD, Principal investigator, Department of Integrative Physiology, University of ColoradoDanielle J. Frey, PT, MS, Study director, Department of Integrative Physiology, University of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383357
- Sponsor's protocol ID
- AG0070
- Other IDs
- 5R03AG024621-02, 5M01RR000051-45
- Status last verified
- Sep 2007
- First submitted
- 28 Sep 2006
- Last updated
- 20 Sep 2007
- Results posted
- No
Publications
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.
PubMed 11037010Luukinen 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.
PubMed 7636094Wertz 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.
PubMed 16403927Frey 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.
PubMed 21226678
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging, Hypnotics, Sleep Inertia and the Risk of Falling
- ClinicalTrials.gov ID
- NCT00383357
- Acronym / sponsor ID
- AG0070
- Keywords
- Performance, Gait stability, sedative, hypnotic, quality of life, sleep disorder, wakefulness, sleeping pills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Aug 2004
- First posted
- 3 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zolpidem | Drug | – |
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
- Background: PubMed 11037010Brassington 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.
- Background: PubMed 7636094Luukinen 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.
- Background: PubMed 16403927Wertz 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.
- Derived from this study: PubMed 21226678Frey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth P. Wright, PhD principal investigator
Department of Integrative Physiology, University of Colorado
Danielle J. Frey, PT, MS study director
Department of Integrative Physiology, University of Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zolpidem in people with Aging and Balance, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383357, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2007.