Trial Outcomes & Findings for Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation (NCT NCT00333619)
NCT ID: NCT00333619
Last Updated: 2015-04-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
3-month follow-up
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
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.
|
Active Control
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).
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
109
|
|
Overall Study
Post-treatment
|
109
|
109
|
|
Overall Study
3-month Follow-up
|
101
|
105
|
|
Overall Study
COMPLETED
|
89
|
99
|
|
Overall Study
NOT COMPLETED
|
21
|
10
|
Reasons for withdrawal
| Measure |
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.
|
Active Control
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).
|
|---|---|---|
|
Overall Study
Death
|
12
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
Baseline characteristics by cohort
| Measure |
Nonpharmacological Sleep Intervention
n=110 Participants
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
|
Active Control
n=109 Participants
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).
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.39 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
73.32 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
72.4 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Pittsburgh Sleep Quality Index
|
7.9 units on a scale; 0-21
STANDARD_DEVIATION 4.1 • n=5 Participants
|
9.2 units on a scale; 0-21
STANDARD_DEVIATION 4.3 • n=7 Participants
|
8.4 units on a scale; 0-21
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sleep efficiency
|
70.3 Percentage of time asleep while in bed
STANDARD_DEVIATION 18.2 • n=5 Participants
|
66.7 Percentage of time asleep while in bed
STANDARD_DEVIATION 20.2 • n=7 Participants
|
68.6 Percentage of time asleep while in bed
STANDARD_DEVIATION 19.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upThe 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).
Outcome measures
| Measure |
Nonpharmacological Sleep Intervention
n=110 Participants
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.
|
Active Control
n=109 Participants
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).
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
|
8.6 units on a scale; 0-21
Standard Deviation 3.8
|
9.4 units on a scale; 0-21
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: 3-month follow-upAverage 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.
Outcome measures
| Measure |
Nonpharmacological Sleep Intervention
n=110 Participants
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.
|
Active Control
n=109 Participants
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).
|
|---|---|---|
|
Sleep Efficiency
|
77.3 percentage of time asleep while in bed
Standard Deviation 14.8
|
71.0 percentage of time asleep while in bed
Standard Deviation 17.6
|
Adverse Events
Nonpharmacological Sleep Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Cathy Alessi
VA Greater Los Angeles Healthcare System
Phone: 818 895-9311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place