Skip to main content
OpenTrials
Completed

NCT Number: NCT00310310

Effect of Self-Management on Improving Sleep Apnea Outcomes

Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Syndromes Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

Background: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization. Objectives: The primary aim of this study is to compare the efficacy of the SASMP to Usual Care for improving OSA symptom status, HRQOL, and self-reported medical utilization. A second aim is to examine the extent to which changes in symptoms and HRQOL are mediated by changes in self-efficacy and CPAP adherence. Methods: We will evaluate the Sleep Apnea Self-Management Program (SASMP) by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group will attend 4 weekly educational sessions of 2.5 hours each. Two trained leaders facilitate the program from a scripted manual. Key topics covered in this program include 1) management of OSA symptoms, CPAP side effects, and weight loss; 2) maintaining social contacts and family relationships; and 3) dealing with symptoms of depression and worries about the future. Findings: No results at this time. Status: We are currently engaging in start-up activities. Impact: The results of this project can improve service delivery and improve health outcomes for sleep apnea patients at the Veterans Affairs San Diego Healthcare System, throughout the VA, as well as to any community based sleep clinic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Apnea Self-Management Program

Behavioral

Sleep apnea self-management program - 4 sessions, group-based.

Usual Care

Behavioral

Usual sleep apnea and cpap care

Primary outcomes

  1. 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.

  2. CPAP Adherence

    Time frame: 6 months

    The investigators also examined the data obtained at the 6-month time point.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

    • A very large, All the time
    • A large
    • A moderate to large
    • A moderate
    • A small to moderate
    • A small
    • No, None, Not at all

  2. 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).

  3. Self-Efficacy

    Time frame: 1 month

    Social-cognitive theory (SCT) measure

    1= Disagree Completely 5= Agree Completely 6= Not applicable

  4. Outcome Expectation

    Time frame: 1 month

    Social-cognitive theory (SCT) measure

    1= Not at all important 5= Extremely important 6= Not applicable

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 3, 2006
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.