Sleep Apnea Syndromes
Conditions
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.
Usual sleep apnea and cpap care
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adherence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy | 1 month | Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable |
| Outcome Expectation | 1 month | Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable |
| Sleep Apnea Quality of Life Index (SAQLI) | 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. 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 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. |
| Center for Epidemiological Studies - Depression Scale (Short Form) | 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. |
| Quality of Well Being Scale (QWB-SA) | 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). |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 240 |
Baseline characteristics
| Characteristic | Usual Care | Self-Management | Total |
|---|---|---|---|
| Age, Continuous | 56.1 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 participants | 120 participants | 240 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 116 Participants | 118 Participants | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
CPAP Adherence
The investigators also examined the data obtained at the 6-month time point.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | CPAP Adherence | 2.3 hours per night | Standard Deviation 2.5 |
| Self-Management | CPAP Adherence | 3.1 hours per night | Standard Deviation 2.5 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | CPAP Adherence | 2.8 hours per night | Standard Deviation 2.6 |
| Self-Management | CPAP Adherence | 3.9 hours per night | Standard Deviation 2.4 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Pittsburgh Sleep Quality Index (PSQI) | 8.5 units on a scale | Standard Deviation 2.9 |
| Self-Management | Pittsburgh Sleep Quality Index (PSQI) | 8.4 units on a scale | Standard Deviation 3.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Pittsburgh Sleep Quality Index (PSQI) | 8.4 units on a scale | Standard Deviation 3.6 |
| Self-Management | Pittsburgh Sleep Quality Index (PSQI) | 8.3 units on a scale | Standard Deviation 3.3 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Center for Epidemiological Studies - Depression Scale (Short Form) | 7.8 units on a scale | Standard Deviation 5.9 |
| Self-Management | Center for Epidemiological Studies - Depression Scale (Short Form) | 7.2 units on a scale | Standard Deviation 5.777 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Epworth Sleepiness Scale (ESS) | 9.2 units on a scale | Standard Deviation 4.8 |
| Self-Management | Epworth Sleepiness Scale (ESS) | 8.1 units on a scale | Standard Deviation 4.8 |
Outcome Expectation
Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Outcome Expectation | 4.1 units on a scale | Standard Deviation 0.9 |
| Self-Management | Outcome Expectation | 4.5 units on a scale | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Quality of Well Being Scale (QWB-SA) | 0.56 units on a scale | Standard Deviation 0.13 |
| Self-Management | Quality of Well Being Scale (QWB-SA) | 0.59 units on a scale | Standard Deviation 14 |
Self-Efficacy
Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self-Efficacy | 3.9 units on a scale | Standard Deviation 1.04 |
| Self-Management | Self-Efficacy | 4.3 units on a scale | Standard Deviation 0.8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Sleep Apnea Quality of Life Index (SAQLI) | 4.9 units on a scale | Standard Deviation 1.04 |
| Self-Management | Sleep Apnea Quality of Life Index (SAQLI) | 5.1 units on a scale | Standard Deviation 0.99 |