Clinical trial NCT03835702: SAMPAP Trial -Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence
Official title: Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Apnea
Keywords: PAP
Group
PAP adherence
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2019-02-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will evaluate people who have moderate-to-severe obstructive sleep apnea (OSA), and have been newly prescribed a Positive Airway Pressure (PAP) machine. Patients with suboptimal adherence, defined by the Center of Medicare and Medicaid criteria (\<70 % usage and \<4 hours of average daily PAP usage) will be identified. The purpose of this research is to examine the impact of the sleep apnea management (SAM) grouped based-intervention on positive airway pressure adherence and patient report outcomes questionnaires (quality of life, daytime sleepiness and depressive symptoms) and PAP barrier questionnaire compared to a patient group managed by regular non-sleep prescribing provider.

Detailed description: The research involves collection of information from the medical record and PAP adherence collection website and completion of a survey at several time points. The survey asks questions about their experience with the therapy, quality of life, daytime sleepiness and depressive symptoms. The participants will also be provided with some literature on sleep hygiene.

Participants will be randomized to one of two groups, Sleep Apnea Management (SAM) Clinic or Usual Care with the non-sleep provider.

Questionnaires. These questionnaires are the Epworth Sleepiness Scale which measures daytime sleepiness, Patient Health Questionnaire which is a 9-item depression scale that provides psychometric measurement of depression, the PAP Barrier Questionnaire, the PROMIS Global Health, a 10-item questionnaire measuring patient reported health status for physical, mental and social well-being, The PROMIS Sleep Related Impairment, 8-item questionnaire used to identify problems in sleep the affect overall quality of sleep and the PROMIS Fatigue, another 8-item questionnaire that evaluates self-reported symptoms of tiredness that affect daily activities and functioning.

If randomized to Sleep Apnea Management (SAM) Clinic patients will be scheduled to attend the SAM Clinic. The SAM is a group clinic created to address challenges in PAP management by promoting adherence by providing access to problem-solving of PAP therapy issues. This allows patients with common problems and needs to have direct access to sleep medicine providers, sleep nurse practitioners, sleep nurses and/or durable medical equipment (DME) representatives all in one room in order to receive the most efficient service.

The questionnaires will be completed at baseline (randomization visit), after 1 month, and again at 3 months.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Moderate to severe OSA (apnea hypopnea index (AHI)≥15 events/hr) on polysomnogram (PSG)
* Followed by non-sleep providers for OSA (mainly primary care providers)
* New PAP set up \< 1 month
* Sub-optimal PAP adherence by objective PAP adherence data (\<70 % usage and \<4 hours of average PAP usage)

Exclusion Criteria:

* Central sleep apnea (\>50% apneas are central) and/or presence of Cheyne-Stokes breathing
* Pregnant women
* Patients on supplemental oxygen
* Patients not able to attend SAM clinic
* Inability to provide informed consent

Primary outcomes:
measure: Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks.
timeFrame: Baseline to 3 month follow up
measure: Percent days of PAP use in last 4 weeks and at 12 weeks.
timeFrame: Baseline to 3 month follow up
Secondary outcomes:
measure: Measure changes in daytime sleepiness at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
timeFrame: Baseline to 3 month follow up
measure: Measure changes in depressive symptoms at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
timeFrame: Baseline to 3 month follow up
measure: Measure changes in global health measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
timeFrame: Baseline to 3 month follow up
measure: Measure changes in fatigue measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
timeFrame: Baseline to 3 month follow up
measure: Measure changes in sleep related impairment measures at 4 weeks and then at 12 weeks in PAP adherence group and in usual care group in study sample.
timeFrame: Baseline to 3 month follow up
Other outcomes:
measure: Changes in PAP Barrier questionnaire (eg. mask fit, nasal congestion, pressure intolerance) from baseline to 1 month and 3 month follow up.
timeFrame: Baseline to 3 month follow up
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Catherine Heinzinger, DO
role: PRINCIPAL_INVESTIGATOR
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