SAMPAP Trial -Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence

NCT03835702 | Completed

• 1 other identifier: 19-110
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

PAP; Group; PAP adherence

Outcome Measures

Primary Outcomes (2)

• Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks.

  To examine the impact of the sleep apnea management (SAM) group-based intervention on Positive Airway Pressure (PAP) adherence compared to a patient group managed by non-sleep medicine physicians (patients who follow usual care and are receptive to the SAM Clinic but do not participate in a SAM group) on changes from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. Greater than 4 hours average daily use is considered adherent.

  Baseline to 3 month follow up

• Percent days of PAP use in last 4 weeks and at 12 weeks.

  To examine the impact of the sleep apnea management (SAM) group-based intervention on Positive Airway Pressure (PAP) adherence compared to a patient group managed by non-sleep medicine physicians (patients who follow usual care and are receptive to the SAM Clinic but do not participate in a SAM group) on changes from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. Greater than 70% usage of days used is considered adherent.

  Baseline to 3 month follow up

Secondary Outcomes (5)

• 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.

  Baseline to 3 month follow up

• 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.

  Baseline to 3 month follow up

• 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.

  Baseline to 3 month follow up

• 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.

  Baseline to 3 month follow up

• 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.

  Baseline to 3 month follow up

Other Outcomes (1)

• Changes in PAP Barrier questionnaire (eg. mask fit, nasal congestion, pressure intolerance) from baseline to 1 month and 3 month follow up.

  Baseline to 3 month follow up

Study Arms (2)

Usual care with non-sleep provider

NO INTERVENTION

Participant will continue the follow up for sleep apnea with the non-sleep provider

SAM Clinic Intervention

EXPERIMENTAL

Participants will attend a sleep apnea management group based intervention to improve PAP adherence.

Other: SAM Clinic Intervention

Interventions

SAM Clinic Intervention OTHER

SAM Clinic is a sleep provider led team comprised of either a sleep clinician or sleep nurse practitioner along with sleep nurses and or durable medical equipment representative. The provider interacts with each patient personally. Various modes of trouble shooting of PAP related issues are tailored to solve PAP adherence issues including mask complaints, nasal issues, pressure intolerance, anxiety, and other related barriers to PAP adherence. When the provider is seeing patients individually other patients have the opportunity to interact and offer informal interpersonal support to other participants in dealing with similar PAP issues. The provider makes an individualized follow-up plan for each patient, which may include another SAM visit or referral back to the non-sleep provider.

SAM Clinic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• ResMed: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Catherine Heinzinger, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Neurologic Institute, Sleep Disorder Center

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 8, 2019
• Study Start: April 1, 2019
• Primary Completion: November 18, 2022
• Study Completion: June 12, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)