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Effect of Self-Management on Improving Sleep Apnea Outcomes

Effect of Self-Management on Improving Sleep Apnea Outcomes

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310310
Enrollment
240
Registered
2006-04-03
Start date
2006-04-30
Completion date
2009-12-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

Continuous positive airway pressure, Patient compliance, Self-care

Brief summary

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.

Detailed description

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.

Interventions

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

BEHAVIORALUsual care

Usual sleep apnea and cpap care

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CPAP Adherence1 monthThe 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.

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index (PSQI)1 MonthThe 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

MeasureTime frameDescription
Self-Efficacy1 monthSocial-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable
Outcome Expectation1 monthSocial-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable
Sleep Apnea Quality of Life Index (SAQLI)1 monthSleep 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. A very large, All the time 2. A large 3. A moderate to large 4. A moderate 5. A small to moderate 6. A small 7. No, None, Not at all
Epworth Sleepiness Scale (ESS)1 monthESS 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.
Center for Epidemiological Studies - Depression Scale (Short Form)1 monthThe 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.
Quality of Well Being Scale (QWB-SA)1 monthThe 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).

Countries

United States

Participant flow

Recruitment details

Participants were recruited and screened from the Pulmonary Sleep/CPAP Clinic at the Veterans Affairs San Diego Healthcare System (VASDHS). Project offices were based at the VASDHS HSR&D unit.

Participants by arm

ArmCount
Usual Care
Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care
120
Self-Management
sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
120
Total240

Baseline characteristics

CharacteristicUsual CareSelf-ManagementTotal
Age, Continuous56.1 years
STANDARD_DEVIATION 12.5
56.3 years
STANDARD_DEVIATION 11.9
56.2 years
STANDARD_DEVIATION 12.2
Region of Enrollment
United States
120 participants120 participants240 participants
Sex: Female, Male
Female
4 Participants2 Participants6 Participants
Sex: Female, Male
Male
116 Participants118 Participants234 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1200 / 120
serious
Total, serious adverse events
0 / 1200 / 120

Outcome results

Primary

CPAP Adherence

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

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Usual CareCPAP Adherence2.3 hours per nightStandard Deviation 2.5
Self-ManagementCPAP Adherence3.1 hours per nightStandard Deviation 2.5
p-value: 0.023t-test, 1 sided
Primary

CPAP Adherence

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.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareCPAP Adherence2.8 hours per nightStandard Deviation 2.6
Self-ManagementCPAP Adherence3.9 hours per nightStandard Deviation 2.4
p-value: 0.001t-test, 1 sided
Secondary

Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: 1 Month

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.

ArmMeasureValue (MEAN)Dispersion
Usual CarePittsburgh Sleep Quality Index (PSQI)8.5 units on a scaleStandard Deviation 2.9
Self-ManagementPittsburgh Sleep Quality Index (PSQI)8.4 units on a scaleStandard Deviation 3.2
p-value: 0.8t-test, 1 sided
Secondary

Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: 6 Months

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities. We had a few Veterans who skipped this assessment when filling out the project assessment packet.

ArmMeasureValue (MEAN)Dispersion
Usual CarePittsburgh Sleep Quality Index (PSQI)8.4 units on a scaleStandard Deviation 3.6
Self-ManagementPittsburgh Sleep Quality Index (PSQI)8.3 units on a scaleStandard Deviation 3.3
Other Pre-specified

Center for Epidemiological Studies - Depression Scale (Short Form)

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.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareCenter for Epidemiological Studies - Depression Scale (Short Form)7.8 units on a scaleStandard Deviation 5.9
Self-ManagementCenter for Epidemiological Studies - Depression Scale (Short Form)7.2 units on a scaleStandard Deviation 5.777
p-value: 0.08t-test, 1 sided
Other Pre-specified

Epworth Sleepiness Scale (ESS)

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.

Time frame: 1 month

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.

ArmMeasureValue (MEAN)Dispersion
Usual CareEpworth Sleepiness Scale (ESS)9.2 units on a scaleStandard Deviation 4.8
Self-ManagementEpworth Sleepiness Scale (ESS)8.1 units on a scaleStandard Deviation 4.8
p-value: 0.38t-test, 1 sided
Other Pre-specified

Outcome Expectation

Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareOutcome Expectation4.1 units on a scaleStandard Deviation 0.9
Self-ManagementOutcome Expectation4.5 units on a scaleStandard Deviation 0.7
p-value: 0.02t-test, 1 sided
Other Pre-specified

Quality of Well Being Scale (QWB-SA)

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).

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareQuality of Well Being Scale (QWB-SA)0.56 units on a scaleStandard Deviation 0.13
Self-ManagementQuality of Well Being Scale (QWB-SA)0.59 units on a scaleStandard Deviation 14
p-value: 0.59t-test, 1 sided
Other Pre-specified

Self-Efficacy

Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareSelf-Efficacy3.9 units on a scaleStandard Deviation 1.04
Self-ManagementSelf-Efficacy4.3 units on a scaleStandard Deviation 0.8
p-value: 0t-test, 1 sided
Other Pre-specified

Sleep Apnea Quality of Life Index (SAQLI)

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. A very large, All the time 2. A large 3. A moderate to large 4. A moderate 5. A small to moderate 6. A small 7. No, None, Not at all

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Usual CareSleep Apnea Quality of Life Index (SAQLI)4.9 units on a scaleStandard Deviation 1.04
Self-ManagementSleep Apnea Quality of Life Index (SAQLI)5.1 units on a scaleStandard Deviation 0.99
p-value: 0.96t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026