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Sleep ApneaNCT03835702

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

A study testing SAM Clinic Intervention in people with Sleep Apnea, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Apnea
What is being tested?
SAM Clinic Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 12 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence: A Randomized Controlled Trial

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.

Read the 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.

Conditions
Sleep Apnea
Being tested
SAM Clinic Intervention
Keywords
PAP, Group, PAP adherence
Medical subject headings
Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAM Clinic InterventionOther

    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.

Study groups in NCT03835702
Study groupRoleWhat they receive
Usual care with non-sleep providerNo interventionParticipant will continue the follow up for sleep apnea with the non-sleep provider
SAM Clinic InterventionExperimentalParticipants will attend a sleep apnea management group based intervention to improve PAP adherence.
Receives: Other: SAM Clinic Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 3 month follow up

  2. 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.

    Measured: Baseline to 3 month follow up

Secondary outcomes (5)

  1. 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.

    To examine and compare changes in patient reported outcomes daytime sleepiness between the SAM Clinic and the usual care arms from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. To examine the correlation between changes in daytime sleepiness to changes in PAP adherence at each time point (secondary analyses).

    The Epworth Sleepiness Scale (ESS) is an 8-question scale that measures subjective daytime sleep propensity. Each question is scored on a scale of 0-3, with a total score possible of 0-24. Greater scores indicate greater daytime sleep propensity, with a score of ≥10 indicating excessive daytime sleep propensity.

    Investigators hypothesize that greater improvement in daytime sleepiness will be noted with the SAM clinic intervention compared to usual care.

    Measured: Baseline to 3 month follow up

  2. 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.

    To compare changes in patient reported outcomes depressive symptoms between the SAM Clinic and the usual care arms from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. To examine the correlation between changes in depressive symptoms to changes in PAP adherence at each time point (secondary analyses). The Patient Health Questionnaire 9 (PHQ-9) is a self-administered survey that assesses each of the 9 DSM-IV criteria for depression in a separate question. Each question is scored from 0-3, with a total possible score of 0-27. Higher scores indicate greater severity of depressive symptoms; a score of 20-27 is indicative of severe depressive symptoms warranting active treatment, 15-19 moderately severe warranting active treatment, 10-14 moderate, 5-9 mild, and 0-4 none/minimal depressive symptoms.

    Investigators hypothesize that greater improvement in depressive symptoms will be noted with the SAM clinic intervention compared to usual care.

    Measured: Baseline to 3 month follow up

  3. 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.

    To compare changes in patient reported outcomes global health between the SAM Clinic and the usual care arms from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. To examine the correlation between changes in global health to changes in PAP adherence at each time point (secondary analyses). The PROMIS Global Health (10 questions) short form measures health. Higher score indicate greater perceived health. The raw sum score is rescaled by a t-score into a standardized score, where a standard score of 50 is the general population average (with a standard deviation of 10). If not all questions were answered, a raw score can be calculated (and later standardized) from the following formula: (Score sum of questions answered * number of questions on the form) ÷Number of questions answered.

    Investigators hypothesize that greater improvement in global health will be noted with the SAM clinic intervention compared to usual care.

    Measured: Baseline to 3 month follow up

  4. 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.

    To compare changes in patient reported outcomes in fatigue between the SAM Clinic and the usual care arms from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. To examine the correlation between changes in fatigue to changes in PAP adherence at each time point (secondary analyses). The PROMIS Fatigue (8 questions) short form measures fatigue. Higher score indicate greater perceived fatigue. The raw sum score is rescaled by a t-score into a standardized score, where a standard score of 50 is the general population average (with a standard deviation of 10). If not all questions were answered, a raw score can be calculated (and later standardized) from the following formula: (Score sum of questions answered * number of questions on the form) ÷Number of questions answered.

    Investigators hypothesize that greater improvement in fatigue will be noted with the SAM clinic intervention compared to usual care.

    Measured: Baseline to 3 month follow up

  5. 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.

    Compare changes in patient reported outcomes in sleep impairment between the SAM Clinic and the usual care arms from baseline to 1 and 3 months in those with moderate to severe OSA with suboptimal PAP adherence. To examine the correlation between changes in sleep impairment to changes in PAP adherence at each time point (secondary analyses). The PROMIS Sleep Related Impairment form measures sleep impairment. Higher score indicate greater perceived impairment. The raw sum score is rescaled by a t-score into a standardized score, where a standard score of 50 is the general population average (with a standard deviation of 10). If not all questions were answered, a raw score can be calculated (and later standardized) from the following formula: (Score sum of questions answered * number of questions on the form) ÷Number of questions answered.

    Investigators hypothesize that greater improvement in sleep impairment will be noted with the SAM clinic intervention compared to usual care.

    Measured: Baseline to 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2019
  2. Study start1 Apr 2019
  3. Primary completion18 Nov 2022
  4. Study completion12 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03835702
Sponsor's protocol ID
19-110
Status last verified
Aug 2025
First submitted
25 Jan 2019
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mehra R. Sleep apnea ABCs: airway, breathing, circulation. Cleve Clin J Med. 2014 Aug;81(8):479-89. doi: 10.3949/ccjm.81gr.14002.

    PubMed 25085986

  • McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

    PubMed 27571048

  • Weaver TE. Adherence to positive airway pressure therapy. Curr Opin Pulm Med. 2006 Nov;12(6):409-13. doi: 10.1097/01.mcp.0000245715.97256.32.

    PubMed 17053489

  • Likar LL, Panciera TM, Erickson AD, Rounds S. Group education sessions and compliance with nasal CPAP therapy. Chest. 1997 May;111(5):1273-7. doi: 10.1378/chest.111.5.1273.

    PubMed 9149582

  • Lewis KE, Bartle IE, Watkins AJ, Seale L, Ebden P. Simple interventions improve re-attendance when treating the sleep apnoea syndrome. Sleep Med. 2006 Apr;7(3):241-7. doi: 10.1016/j.sleep.2005.09.007. Epub 2006 Mar 24.

    PubMed 16564210

  • Lettieri CJ, Walter RJ. Impact of group education on continuous positive airway pressure adherence. J Clin Sleep Med. 2013 Jun 15;9(6):537-41. doi: 10.5664/jcsm.2742.

    PubMed 23772185

  • Walia HK, Griffith SD, Thompson NR, Moul DE, Foldvary-Schaefer N, Mehra R. Impact of Sleep-Disordered Breathing Treatment on Patient Reported Outcomes in a Clinic-Based Cohort of Hypertensive Patients. J Clin Sleep Med. 2016 Oct 15;12(10):1357-1364. doi: 10.5664/jcsm.6188.

    PubMed 27568910

  • Walia HK, Thompson NR, Katzan I, Foldvary-Schaefer N, Moul DE, Mehra R. Impact of Sleep-Disordered Breathing Treatment on Quality of Life Measures in a Large Clinic-Based Cohort. J Clin Sleep Med. 2017 Nov 15;13(11):1255-1263. doi: 10.5664/jcsm.6792.

    PubMed 28992832

  • Aurora RN, Collop NA, Jacobowitz O, Thomas SM, Quan SF, Aronsky AJ. Quality measures for the care of adult patients with obstructive sleep apnea. J Clin Sleep Med. 2015 Mar 15;11(3):357-83. doi: 10.5664/jcsm.4556.

    PubMed 25700878

  • Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep. 1992 Aug;15(4):376-81. doi: 10.1093/sleep/15.4.376.

    PubMed 1519015

  • Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J. Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD Patient Health Questionnaire Obstetrics-Gynecology Study. Am J Obstet Gynecol. 2000 Sep;183(3):759-69. doi: 10.1067/mob.2000.106580.

    PubMed 10992206

  • Weaver TE, Laizner AM, Evans LK, Maislin G, Chugh DK, Lyon K, Smith PL, Schwartz AR, Redline S, Pack AI, Dinges DF. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep. 1997 Oct;20(10):835-43.

    PubMed 9415942

  • Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.

    PubMed 27018174

  • Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981 Jun;2(2):93-113. doi: 10.1016/0197-2456(81)90001-5.

    PubMed 7273794

Questions about this trial

What is this clinical trial studying?

A study testing SAM Clinic Intervention in people with Sleep Apnea, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks. (time frame: Baseline to 3 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03835702, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.

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