Sleep Apnea, Obstructive
Conditions
Keywords
Continuous Positive Airway Pressure, Patient Compliance, Intervention Studies, Spouses
Brief summary
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
Detailed description
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor. CPAP adherence interventions to date have been met with limited success. Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery. Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness. Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential. The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning. Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
Interventions
BEHAVIORALCouple-oriented intervention
The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours. This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
BEHAVIORALPatient-oriented intervention
The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours. This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes. The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
DEVICEContinuous positive airway pressure (CPAP)
CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
OTHERNo intervention
No intervention will be received.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient: * Age is 21 years of age and older * Have spouse or partner * Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5) * Choice of continuous positive airway pressure (CPAP) as preferred treatment Partner: * Age is 18 years of age and older * Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment
Exclusion criteria
Patient: * AHI \< 5 on the diagnostic PSG * Have a spouse or partner with OSA diagnosis and on OSA treatment * Past treatment for OSA * Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia) * Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma) * History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner: * Have been diagnosed with OSA and using CPAP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Sleepiness | baseline and 3 months after CPAP initiation | The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness. |
| Sleep-related Functional Outcomes | baseline and 3 months after CPAP initiation | The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning. |
| Sleep Quality | baseline and 3 months after CPAP initiation | The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score \> 5 indicates a poor sleeper. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) Adherence | one week, one month, and 3 months after CPAP initiation | Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients in the Couple-oriented Intervention Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions and participate in an individual telephone follow-up session.
Couple-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the couple with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use. | 5 |
| Partners in the Couple-oriented Intervention Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session. | 5 |
| Patients in the Patient-oriented Intervention Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.
Patient-oriented intervention: The first session will occur before the patient receives his/her CPAP. This session will provide the patient with education on sleep apnea and CPAP, demonstration of PAP equipment, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP. The second session will provide the patient with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP. This session will review CPAP usage and explore barriers and facilitators of CPAP use. | 6 |
| Partners in the Patient-oriented Intervention Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions. | 6 |
| Patients in Usual Care Patients will not attend any intervention sessions. | 9 |
| Partners in Usual Care Partners will not attend any intervention sessions | 9 |
| Total | 40 |
Baseline characteristics
| Characteristic | Patients in the Couple-oriented Intervention | Total | Partners in Usual Care | Patients in Usual Care | Partners in the Patient-oriented Intervention | Patients in the Patient-oriented Intervention | Partners in the Couple-oriented Intervention |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 14 | 52 years STANDARD_DEVIATION 10 | 54 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 3 |
| Apnea-Hypopnea Index | 40 Events per hour of sleep STANDARD_DEVIATION 40 | 37 Events per hour of sleep STANDARD_DEVIATION 31 | NA Events per hour of sleep | 40 Events per hour of sleep STANDARD_DEVIATION 28 | NA Events per hour of sleep | 30 Events per hour of sleep STANDARD_DEVIATION 32 | NA Events per hour of sleep |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 12 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 23 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 1 Participants | 19 Participants | 6 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 21 Participants | 3 Participants | 6 Participants | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Daytime Sleepiness
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of \> 10 indicates excessive daytime sleepiness.
Time frame: baseline and 3 months after CPAP initiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in the Couple-oriented Intervention | Daytime Sleepiness | 3 month follow-up | 4.2 units on a scale | Standard Deviation 0.8 |
| Patients in the Couple-oriented Intervention | Daytime Sleepiness | Baseline | 9.0 units on a scale | Standard Deviation 6.9 |
| Patients in the Couple-oriented Intervention | Daytime Sleepiness | Change from Baseline to 3 months | -4.8 units on a scale | Standard Deviation 0.8 |
| Partners in the Couple-oriented Intervention | Daytime Sleepiness | 3 month follow-up | 1.5 units on a scale | Standard Deviation 2.5 |
| Partners in the Couple-oriented Intervention | Daytime Sleepiness | Baseline | 3.8 units on a scale | Standard Deviation 1.9 |
| Partners in the Couple-oriented Intervention | Daytime Sleepiness | Change from Baseline to 3 months | -1.8 units on a scale | Standard Deviation 1 |
| Patients in the Patient-oriented Intervention | Daytime Sleepiness | 3 month follow-up | 3.3 units on a scale | Standard Deviation 2.1 |
| Patients in the Patient-oriented Intervention | Daytime Sleepiness | Baseline | 6.8 units on a scale | Standard Deviation 6.8 |
| Patients in the Patient-oriented Intervention | Daytime Sleepiness | Change from Baseline to 3 months | -3.5 units on a scale | Standard Deviation 6.7 |
| Partners in the Patient-oriented Intervention | Daytime Sleepiness | 3 month follow-up | 6.9 units on a scale | Standard Deviation 4.5 |
| Partners in the Patient-oriented Intervention | Daytime Sleepiness | Baseline | 6.5 units on a scale | Standard Deviation 4.6 |
| Partners in the Patient-oriented Intervention | Daytime Sleepiness | Change from Baseline to 3 months | 0.4 units on a scale | Standard Deviation 4.2 |
| Patients in Usual Care | Daytime Sleepiness | 3 month follow-up | 6.4 units on a scale | Standard Deviation 4.8 |
| Patients in Usual Care | Daytime Sleepiness | Baseline | 10.8 units on a scale | Standard Deviation 5.9 |
| Patients in Usual Care | Daytime Sleepiness | Change from Baseline to 3 months | -4.3 units on a scale | Standard Deviation 4.6 |
| Partners in Usual Care | Daytime Sleepiness | Baseline | 7.3 units on a scale | Standard Deviation 5.2 |
| Partners in Usual Care | Daytime Sleepiness | Change from Baseline to 3 months | -2.7 units on a scale | Standard Deviation 3.1 |
| Partners in Usual Care | Daytime Sleepiness | 3 month follow-up | 4.7 units on a scale | Standard Deviation 3.4 |
Primary
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score \> 5 indicates a poor sleeper.
Time frame: baseline and 3 months after CPAP initiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in the Couple-oriented Intervention | Sleep Quality | 3 month follow-up | 5.0 units on a scale | Standard Deviation 3.4 |
| Patients in the Couple-oriented Intervention | Sleep Quality | Baseline | 8.4 units on a scale | Standard Deviation 2.5 |
| Patients in the Couple-oriented Intervention | Sleep Quality | Change from Baseline to 3 months | -4.3 units on a scale | Standard Deviation 3.1 |
| Partners in the Couple-oriented Intervention | Sleep Quality | 3 month follow-up | 6.4 units on a scale | Standard Deviation 5 |
| Partners in the Couple-oriented Intervention | Sleep Quality | Baseline | 7.0 units on a scale | Standard Deviation 2.9 |
| Partners in the Couple-oriented Intervention | Sleep Quality | Change from Baseline to 3 months | -1.5 units on a scale | Standard Deviation 3.5 |
| Patients in the Patient-oriented Intervention | Sleep Quality | 3 month follow-up | 5.8 units on a scale | Standard Deviation 3.7 |
| Patients in the Patient-oriented Intervention | Sleep Quality | Baseline | 7.8 units on a scale | Standard Deviation 3.1 |
| Patients in the Patient-oriented Intervention | Sleep Quality | Change from Baseline to 3 months | -2.0 units on a scale | Standard Deviation 1.7 |
| Partners in the Patient-oriented Intervention | Sleep Quality | 3 month follow-up | 7.4 units on a scale | Standard Deviation 3.7 |
| Partners in the Patient-oriented Intervention | Sleep Quality | Baseline | 7.2 units on a scale | Standard Deviation 2.1 |
| Partners in the Patient-oriented Intervention | Sleep Quality | Change from Baseline to 3 months | -1.8 units on a scale | Standard Deviation 2.2 |
| Patients in Usual Care | Sleep Quality | 3 month follow-up | 6.1 units on a scale | Standard Deviation 5.8 |
| Patients in Usual Care | Sleep Quality | Baseline | 8.3 units on a scale | Standard Deviation 4.5 |
| Patients in Usual Care | Sleep Quality | Change from Baseline to 3 months | -2.2 units on a scale | Standard Deviation 4.9 |
| Partners in Usual Care | Sleep Quality | Baseline | 9.9 units on a scale | Standard Deviation 3 |
| Partners in Usual Care | Sleep Quality | Change from Baseline to 3 months | -2.7 units on a scale | Standard Deviation 4.4 |
| Partners in Usual Care | Sleep Quality | 3 month follow-up | 7.3 units on a scale | Standard Deviation 2.8 |
Primary
Sleep-related Functional Outcomes
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.
Time frame: baseline and 3 months after CPAP initiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in the Couple-oriented Intervention | Sleep-related Functional Outcomes | 3 month follow-up | 17.9 units on a scale | Standard Deviation 0.9 |
| Patients in the Couple-oriented Intervention | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 2.1 units on a scale | Standard Deviation 3 |
| Patients in the Couple-oriented Intervention | Sleep-related Functional Outcomes | Baseline | 16.6 units on a scale | Standard Deviation 2.6 |
| Partners in the Couple-oriented Intervention | Sleep-related Functional Outcomes | 3 month follow-up | 18.2 units on a scale | Standard Deviation 2.1 |
| Partners in the Couple-oriented Intervention | Sleep-related Functional Outcomes | Baseline | 16.7 units on a scale | Standard Deviation 2.6 |
| Partners in the Couple-oriented Intervention | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 1.5 units on a scale | Standard Deviation 0.7 |
| Patients in the Patient-oriented Intervention | Sleep-related Functional Outcomes | 3 month follow-up | 19.1 units on a scale | Standard Deviation 1.5 |
| Patients in the Patient-oriented Intervention | Sleep-related Functional Outcomes | Baseline | 17.2 units on a scale | Standard Deviation 3.3 |
| Patients in the Patient-oriented Intervention | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 1.9 units on a scale | Standard Deviation 3.7 |
| Partners in the Patient-oriented Intervention | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 0.0 units on a scale | Standard Deviation 1.8 |
| Partners in the Patient-oriented Intervention | Sleep-related Functional Outcomes | Baseline | 16.9 units on a scale | Standard Deviation 3.9 |
| Partners in the Patient-oriented Intervention | Sleep-related Functional Outcomes | 3 month follow-up | 17.3 units on a scale | Standard Deviation 2.9 |
| Patients in Usual Care | Sleep-related Functional Outcomes | Baseline | 15.6 units on a scale | Standard Deviation 4.3 |
| Patients in Usual Care | Sleep-related Functional Outcomes | 3 month follow-up | 17.7 units on a scale | Standard Deviation 2.8 |
| Patients in Usual Care | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 2.1 units on a scale | Standard Deviation 3.3 |
| Partners in Usual Care | Sleep-related Functional Outcomes | 3 month follow-up | 18.0 units on a scale | Standard Deviation 1.6 |
| Partners in Usual Care | Sleep-related Functional Outcomes | Baseline | 17.3 units on a scale | Standard Deviation 2.4 |
| Partners in Usual Care | Sleep-related Functional Outcomes | Change from Baseline to 3 months | 0.8 units on a scale | Standard Deviation 1.1 |
Secondary
Continuous Positive Airway Pressure (CPAP) Adherence
Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.
Time frame: one week, one month, and 3 months after CPAP initiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 3 months | 5.3 hours of use | Standard Deviation 2.9 |
| Patients in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 week to 1 month | 1.4 hours of use | Standard Deviation 1.9 |
| Patients in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 week | 5.6 hours of use | Standard Deviation 2.8 |
| Patients in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 month | 6.1 hours of use | Standard Deviation 0.8 |
| Patients in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 month to 3 months | -1.6 hours of use | Standard Deviation 1.8 |
| Partners in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 week to 1 month | 0.5 hours of use | Standard Deviation 0.8 |
| Partners in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 week | 4.5 hours of use | Standard Deviation 2.6 |
| Partners in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 month | 5.0 hours of use | Standard Deviation 2.9 |
| Partners in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 3 months | 4.5 hours of use | Standard Deviation 2.8 |
| Partners in the Couple-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 month to 3 months | -0.5 hours of use | Standard Deviation 0.6 |
| Patients in the Patient-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 month to 3 months | -0.3 hours of use | Standard Deviation 1 |
| Patients in the Patient-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 3 months | 4.8 hours of use | Standard Deviation 2.4 |
| Patients in the Patient-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 week | 5.8 hours of use | Standard Deviation 2.4 |
| Patients in the Patient-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | Change from 1 week to 1 month | -0.7 hours of use | Standard Deviation 0.7 |
| Patients in the Patient-oriented Intervention | Continuous Positive Airway Pressure (CPAP) Adherence | 1 month | 5.1 hours of use | Standard Deviation 2.3 |