Sleep Disorders
Conditions
Keywords
sleep disorders, rehabilitation, rehabilitation outcomes
Brief 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.
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.
Interventions
BEHAVIORALNonpharmacological sleep intervention
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
BEHAVIORALActive control
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).
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nonpharmacological Sleep Intervention 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.
Nonpharmacological sleep intervention: 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 | 110 |
| Active Control 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).
Active control: 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). | 109 |
| Total | 219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 6 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | Total | Nonpharmacological Sleep Intervention | Active Control |
|---|---|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 9.98 | 71.39 years STANDARD_DEVIATION 9.78 | 73.32 years STANDARD_DEVIATION 10.12 |
| Pittsburgh Sleep Quality Index | 8.4 units on a scale; 0-21 STANDARD_DEVIATION 4.5 | 7.9 units on a scale; 0-21 STANDARD_DEVIATION 4.1 | 9.2 units on a scale; 0-21 STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 211 Participants | 105 Participants | 106 Participants |
| Sleep efficiency | 68.6 Percentage of time asleep while in bed STANDARD_DEVIATION 19.3 | 70.3 Percentage of time asleep while in bed STANDARD_DEVIATION 18.2 | 66.7 Percentage of time asleep while in bed STANDARD_DEVIATION 20.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 110 | 0 / 109 |
| serious Total, serious adverse events | 0 / 110 | 0 / 109 |
Outcome results
Primary
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).
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonpharmacological Sleep Intervention | Pittsburgh Sleep Quality Index | 8.6 units on a scale; 0-21 | Standard Deviation 3.8 |
| Active Control | Pittsburgh Sleep Quality Index | 9.4 units on a scale; 0-21 | Standard Deviation 3.8 |
p-value: 0.1ANOVA
Primary
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.
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nonpharmacological Sleep Intervention | Sleep Efficiency | 77.3 percentage of time asleep while in bed | Standard Deviation 14.8 |
| Active Control | Sleep Efficiency | 71.0 percentage of time asleep while in bed | Standard Deviation 17.6 |
p-value: 0.12ANOVA