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Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

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ClinicalTrials.gov Identifier: NCT00333619
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : April 6, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Disorders
Interventions Behavioral: Nonpharmacological sleep intervention
Behavioral: Active control
Enrollment 219
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nonpharmacological Sleep Intervention Active Control
Hide Arm/Group Description 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: 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).
Period Title: Overall Study
Started 110 109
Post-treatment 109 109
3-month Follow-up 101 105
Completed 89 99
Not Completed 21 10
Reason Not Completed
Death             12             6
Withdrawal by Subject             6             1
Lost to Follow-up             3             3
Arm/Group Title Nonpharmacological Sleep Intervention Active Control Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 110 109 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 109 participants 219 participants
71.39  (9.78) 73.32  (10.12) 72.4  (9.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 109 participants 219 participants
Female
5
   4.5%
3
   2.8%
8
   3.7%
Male
105
  95.5%
106
  97.2%
211
  96.3%
Pittsburgh Sleep Quality Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale; 0-21
Number Analyzed 110 participants 109 participants 219 participants
7.9  (4.1) 9.2  (4.3) 8.4  (4.5)
[1]
Measure Description: 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   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of time asleep while in bed
Number Analyzed 110 participants 109 participants 219 participants
70.3  (18.2) 66.7  (20.2) 68.6  (19.3)
[1]
Measure Description: 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.
1.Primary Outcome
Title Pittsburgh Sleep Quality Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonpharmacological Sleep Intervention Active Control
Hide Arm/Group Description:
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: 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 Number of Participants Analyzed 110 109
Mean (Standard Deviation)
Unit of Measure: units on a scale; 0-21
8.6  (3.8) 9.4  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nonpharmacological Sleep Intervention, Active Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Sleep Efficiency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonpharmacological Sleep Intervention Active Control
Hide Arm/Group Description:

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

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).

Overall Number of Participants Analyzed 110 109
Mean (Standard Deviation)
Unit of Measure: percentage of time asleep while in bed
77.3  (14.8) 71.0  (17.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nonpharmacological Sleep Intervention, Active Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame This was a behavioral sleep education intervention. No medications or devices were tested. Data on adverse events were collected over the entire study period (12-months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nonpharmacological Sleep Intervention Active Control
Hide Arm/Group Description

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

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).

All-Cause Mortality
Nonpharmacological Sleep Intervention Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nonpharmacological Sleep Intervention Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/110 (0.00%)   0/109 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nonpharmacological Sleep Intervention Active Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/110 (0.00%)   0/109 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Cathy Alessi
Organization: VA Greater Los Angeles Healthcare System
Phone: 818 895-9311
EMail: cathy.alessi@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00333619    
Other Study ID Numbers: IIR 04-321
First Submitted: June 2, 2006
First Posted: June 6, 2006
Results First Submitted: October 23, 2014
Results First Posted: April 6, 2015
Last Update Posted: April 24, 2015