- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310310
Effect of Self-Management on Improving Sleep Apnea Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of obstructive sleep apnea
- No previous use of CPAP
- Must be a Veteran with residence within San Diego County
Exclusion Criteria:
- Home oxygen therapy
- Fatal comorbidities (i.e., life expectancy less than 6 mos)
- Contraindications for CPAP use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Usual Care
Usual sleep apnea and cpap care
|
Usual sleep apnea and cpap care
|
Experimental: Self-Management
sleep apnea self-management program - 4 sessions, group-based
|
Sleep apnea self-management program - 4 sessions, group-based.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CPAP Adherence
Time Frame: 1 month
|
The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.
|
1 month
|
CPAP Adherence
Time Frame: 6 months
|
The investigators also examined the data obtained at the 6-month time point.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 Month
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
1 Month
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 6 Months
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
6 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Apnea Quality of Life Index (SAQLI)
Time Frame: 1 month
|
Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects.
|
1 month
|
Quality of Well Being Scale (QWB-SA)
Time Frame: 1 month
|
The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations.
The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions.
The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity.
The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).
|
1 month
|
Self-Efficacy
Time Frame: 1 month
|
Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable |
1 month
|
Outcome Expectation
Time Frame: 1 month
|
Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable |
1 month
|
Center for Epidemiological Studies - Depression Scale (Short Form)
Time Frame: 1 month
|
The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity. The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed. |
1 month
|
Epworth Sleepiness Scale (ESS)
Time Frame: 1 month
|
ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings.
Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely).
The situations are designed to vary in sleep-inducing capacity.
The ESS scoring range is 0-24, with higher scores reflecting greater daytime sleepiness.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carl J Stepnowsky, PhD, San Diego Veterans Healthcare System
Publications and helpful links
General Publications
- Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med. 2007;5(2):131-46. doi: 10.1080/15402000701190622.
- Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
- Stepnowsky CJ, Ancoli-Israel S. Sleep and Its Disorders in Seniors. Sleep Med Clin. 2008;3(2):281-293. doi: 10.1016/j.jsmc.2008.01.011. No abstract available.
- Deering S, Liu L, Zamora T, Hamilton J, Stepnowsky C. CPAP Adherence is Associated With Attentional Improvements in a Group of Primarily Male Patients With Moderate to Severe OSA. J Clin Sleep Med. 2017 Dec 15;13(12):1423-1428. doi: 10.5664/jcsm.6838.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 02-275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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