Sleep DisordersNCT00333619
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
A study testing Nonpharmacological sleep intervention in people with Sleep Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- Nonpharmacological sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation
Who cannot join
- severe sleep apnea
- severe cognitive impairment
- not enrolled within one week of admission to rehabilitation unit
- too ill to participate
- and planned discharge to a nursing home for total nursing care
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.
Read the detailed description
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.
This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.
- Conditions
- Sleep Disorders
- Being tested
- Nonpharmacological sleep intervention, Active control
- Keywords
- sleep disorders, rehabilitation, rehabilitation outcomes
- 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.
Nonpharmacological sleep interventionBehavioural
The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
Active controlBehavioural
Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
| Study group | Role | What they receive |
|---|---|---|
| Nonpharmacological sleep intervention | Experimental | The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. Receives: Behavioral: Nonpharmacological sleep intervention |
| Active control | Active comparator | Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). Receives: Behavioral: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).
Measured: 3-month follow-up
Sleep Efficiency
Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cathy A. Alessi, MD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333619
- Sponsor's protocol ID
- IIR 04-321
- Status last verified
- Oct 2014
- First submitted
- 2 Jun 2006
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1.
PubMed 22617164Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2.
PubMed 21450184Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8.
PubMed 23834036
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
- ClinicalTrials.gov ID
- NCT00333619
- Acronym / sponsor ID
- IIR 04-321
- Conditions
- Sleep Disorders
- Keywords
- sleep disorders, rehabilitation, rehabilitation outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.
Detailed description
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.
This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonpharmacological sleep intervention | Experimental | Behavioral: Nonpharmacological sleep interventionThe intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies. |
| Active control | Active comparator | Behavioral: Active controlDaily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation
Key exclusion criteria (5 listed)
- severe sleep apnea
- severe cognitive impairment
- not enrolled within one week of admission to rehabilitation unit
- too ill to participate
- and planned discharge to a nursing home for total nursing care
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 |
|---|---|---|
| Nonpharmacological sleep interventionThe intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies | Behavioural | Nonpharmacological sleep intervention |
| Active controlDaily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions). | Behavioural | Active control |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 3-month follow-up
The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).
Sleep Efficiency
Time frame: 3-month follow-up
Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22617164Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1.
- Results publication: PubMed 21450184Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2.
- Results publication: PubMed 23834036Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8.
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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.
Cathy A. Alessi, MD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonpharmacological sleep intervention in people with Sleep Disorders, run by US Department of Veterans Affairs 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 1 inclusion and 5 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 24 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pittsburgh Sleep Quality Index (time frame: 3-month follow-up). 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 NCT00333619, which also lists 3 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 24 Apr 2015.