Study design overview
This is a two-arm, parallel-group, single-blind, randomized controlled pilot trial to evaluate the feasibility and preliminary effectiveness of “We-PAP”, a novel, couples-based sleep health intervention for patients with OSA and their partners compared to an information control (IC). Participants include patients who are newly diagnosed with OSA and starting PAP therapy and their partners (n = 40). After completing a pre-treatment baseline assessment, couples are randomly assigned to either a 3-session online sleep health intervention (We-PAP) or to a patient-focused information control group (IC) arm. Patients and partners complete follow-up assessments at post-treatment (approximately 1 month after starting PAP) and 3 months after starting PAP treatment. Approval for this on-going study was provided by the University of Utah Institutional Review Board (IRB_000135927). The study is registered with ClinicalTrials.gov (NCT04759157, 2/13/2021).
Theoretical framework
We-PAP is based on the transdiagnostic sleep and circadian model (i.e., a treatment that addresses common components of multiple disorders rather than a single disorder)37. Consistent with key, evidence-based principles from couples-based interventions for other chronic health conditions, We-PAP conceptualizes PAP adherence and both partners’ sleep health as a “shared” experience and delivers education and intervention through the lens of the couples’ shared sleep goals and challenges. The treatment provides education on sleep regulation and the importance of sleep for health, then uses specific techniques for both OSA and insomnia symptoms based on best practices in cognitive behavioral (CBT) strategies to promote PAP adherence and Brief Behavioral Treatment for Insomnia (BBTI, e.g. consistent schedules, limiting napping)38–40. The conceptual framework of the intervention emphasizes education, as well as two couples-based themes that are integrated throughout the intervention. First, dyadic coping refers to the recognition that the illness (OSA) affects both members of the couple, which evokes a coping response in both members. Therefore, We-PAP helps OSA patients and partners conceptualize PAP adherence and both of their sleep health issues as a couple-level problem (i.e., a “we problem”). The second theme focuses on enhancing communication to promote collaborative support within the couple and reduce conflict. Substantial research in couples shows that while a supportive partner is crucial for supporting an array of health behaviors, including diet, physical activity, sleep, and treatment adherence, a high conflict relationship is a primary source of stress, which can undermine health behaviors12,41−43.
Recruitment, screening and consent
A total of 40 couples are being recruited from the University of Utah Health Sleep Centers. Patients who are undergoing testing (in-lab or home sleep testing) are provided a letter introducing the study and notifying them they may be contacted about the study. Study staff contact potential patients via phone and email to provide study information and if interested, conduct screening for study eligibility. After completing screening, couples schedule an online consent visit over zoom to review and sign the online consent form and arrange to complete the baseline assessment.
Eligibility criteria
Inclusion criteria for the couple include: 1) Age 50–85 years; 2) Married or living with a romantic partner for at least 1 year; 3) Patient is PAP naïve or re-initiating PAP after 3 or more years; 4) Able to read and write in English; 5) Able to access online, video-conference capabilities (Wi-Fi or cellular plan)
Exclusion criteria include: 1) Self-reported diagnosis of severe comorbid sleep disorders other than insomnia (e.g., moderate or severe RLS; REM Behavior Disorder, narcolepsy); 2) Presence of severe medical and psychiatric disorders that would interfere with participation in treatment (schizophrenia, bipolar disorder, hemodialysis); 3) Patient is using supplemental oxygen or adaptive servo-ventilation.
Randomization
Upon completion of the baseline assessment, couples are randomly assigned to either We-PAP or IC using the RedCAP randomization algorithm. The randomization table, developed by the statistician (BB), uses a 1:1 ratio of We-PAP to IC with equal strata for male and female patients using a random number generator. The study interventionist confirms with the study staff that the couple meet the eligibility criteria then contacts the couple via letter and email to notify them of their group assignment.
Assessment schedule
At baseline/pretreatment, couples complete questionnaires, 7 days of wrist actigraphy and daily sleep diaries (delivered either via text message or on paper), and a brief cognitive testing battery. Approximately 1 month after beginning PAP and upon completion of their intervention, couples complete a second set of questionnaires. Finally, at 3 months after starting PAP, couples complete questionnaires, 7 days of actigraphy and daily sleep diaries and a brief cognitive testing battery. PAP use data is collected via download using the corresponding cloud based system.
Intervention description
We-Pap was developed through an iterative process that included focus groups and a brief field trial (n = 4 couples) before beginning the RCT. This intervention is a novel, couples-focused PAP adherence and sleep health treatment that combines a transdiagnostic sleep and circadian framework with a dyadic (i.e., couples) perspective. Together, patients and partners assigned to the We-PAP intervention complete three online Zoom-hosted, videoconference-based educational sessions conducted weekly, which utilize structured PowerPoint slides. All sessions include the themes of sleep education, dyadic coping and communication.
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Session 1 (75 minutes) focuses on assessment and the couples’ sleep, knowledge about OSA and expectations for beginning PAP
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Session 2 (60 minutes) focuses on sleep health and strategies to improve poor sleep (techniques based in BBTI)
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Session 3 (60 minutes) continues the discussion about strategies for improving sleep health, including adjusting the sleep window and also relaxation strategies (for adjusting to PAP and also for improving sleep health in general).
During each session, the interventionist reviews homework (if applicable), presents session content, engages the couple in discussion and planning and assigns homework for the next session (if applicable).
Information control (IC)
In this group, couples receive a packet of standardized patient educational materials about OSA and PAP published by the American Academy of Sleep Medicine on the website Sleepeducation.org. In addition to notifying participants in this group of their group assignment, the interventionist contacts couples to ensure they have received the study materials. If the couple has questions about PAP, the interventionist refers couples to direct questions to their sleep medicine provider or durable medical equipment (DME) company.
Interventionist training, supervision, and fidelity monitoring
All We-Pap intervention sessions are recorded for training and fidelity monitoring. The interventionist delivering the We-PAP intervention content has a doctoral degree in clinical psychology and is currently participating in a Behavioral Sleep Medicine Fellowship program. Training included didactics, supervised telehealth patient sessions focused on CBTi at the University of Utah Sleep Wake Center, rehearsal of We-Pap sessions prior to the field trial, role-playing, review of pre-recorded session format provided by the lead investigators, in-person review and coaching of digitally recorded field trial sessions, and weekly supervision meetings. The interventionist is supervised by one of the lead investigators (WT). Fidelity is monitored via a structured checklist completed by the therapist at the end of each session and 10% of sessions will be rated for fidelity by one of the lead investigators (WT or KB). The checklist also includes an open-ended comments section, where the interventionist writes notes to review in weekly meetings with the supervisor.
Measures
Participants complete a brief demographic measure, including age, sex, race / ethnicity, marital status, education level, employment status, household income level, substance use, and bed-sharing.
OSA severity (AHI) will be extracted from medical records.
Feasibility and acceptability measures
A combination of quantitative and qualitative measures to assess the feasibility and acceptability of the study are used. Such methods include percentage of participants completing intervention sessions, ratings of ease of participation in the telehealth, questions about the number and duration of sessions, and perceived benefits of the intervention and enjoyment of the sessions. Additionally couples will be asked open-ended questions about the format, feedback on the content, materials and general feedback and suggestions for improving the interventions.
Primary outcome measures
PAP adherence – Patient PAP adherence is recorded by the patient’s PAP machine and remotely downloaded. PAP adherence is measured continuously. The main time point for adherence is at 3 months. The average duration of use per night, % of nights with use > 4 hours, and nights skipped is recorded.
Secondary outcome measures
Objective Sleep Measures
Sleep is estimated using the Actiwatch Spectrum Plus (Philips Respironics, Murrysville, PA, USA). Actiwatches are configured with default settings using 30-second epochs. Rest intervals are manually set with assistance of a sleep diary (to indicate bedtimes and wake times). Using the Actiware software, we calculate total sleep time, sleep onset time, sleep offset time, sleep duration, sleep efficiency, sleep latency, wake after sleep onset, and sleep fragmentation index. The main measure of sleep quality is sleep efficiency.
Sleep diary
Participants complete the Consensus Sleep Diary44 to quantitatively assess dimensions of sleep that are important for a wide-range of clinical and research applications. Items include time the individual got into and out of bed, time the individual tried to go to sleep, duration to fall asleep, and frequency and total duration of awakenings, time of final awakening and sleep quality rating. Two additional items included in the diary assess whether partners shared a bed (yes/no) and the degree to which the couple worked together to use CPAP (rated on a scale 1–5).
Sleep disturbance and sleep-related impairment
Participants complete the PROMIS sleep disturbance and sleep-related impairment adaptive measures45 Scores are presented as t-scores, with average of 50 and SD of 10. Scores > 60 are considered elevated. Self-reported sleep is measured using a standardized sleep diary and the PROMIS sleep disturbance questionnaire.
Other outcome measures
Relationship quality
Participants complete the Couples Satisfaction Index (CSI-4)46 to evaluate an individual’s self-reported degree of satisfaction, happiness, warmth and comfort, and reward with the relationship. The 4-items on the scale are summed and range from 0 to 21. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction.
Cognitive function
A study staff member administers the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) forms A and B via videoconference (Zoom)47. This 30 min validated clinical measure was designed to assess cognitive status in adults and older adults. The five sub-scores include attention, language, visuospatial/construction, immediate and delayed memory as well as a total score. In order to complete this measure via teleconference, couples are mailed the coding subtest in a sealed envelope and told not to open it until the assessment. Then they are asked to place the completed test in a sealed envelope during the testing session.