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

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ClinicalTrials.gov Identifier: NCT03835702
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
Harneet Walia, MD, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Other: SAM Clinic Intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Novel Sleep Apnea Management Group Intervention on Positive Airway Pressure Adherence: A Randomized Controlled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: Usual care with non-sleep provider
Participant will continue the follow up for sleep apnea with the non-sleep provider
Experimental: SAM Clinic Intervention
Participants will attend a sleep apnea management group based intervention to improve PAP adherence.
Other: SAM Clinic Intervention
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.




Primary Outcome Measures :
  1. Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks. [ Time Frame: Baseline to 3 month follow up ]

    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.


  2. Percent days of PAP use in last 4 weeks and at 12 weeks. [ Time Frame: Baseline to 3 month follow up ]

    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.



Secondary Outcome Measures :
  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. [ Time Frame: Baseline to 3 month follow up ]

    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.


  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. [ Time Frame: Baseline to 3 month follow up ]

    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.


  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. [ Time Frame: Baseline to 3 month follow up ]

    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.


  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. [ Time Frame: Baseline to 3 month follow up ]

    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.


  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. [ Time Frame: Baseline to 3 month follow up ]

    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.



Other Outcome Measures:
  1. Changes in PAP Barrier questionnaire (eg. mask fit, nasal congestion, pressure intolerance) from baseline to 1 month and 3 month follow up. [ Time Frame: Baseline to 3 month follow up ]

    Examine the impact of the SAM Clinic on changes in barriers to PAP adherence compared to usual care from baseline contact to 3 months in those with moderate to severe OSA with suboptimal PAP adherence.

    The Barriers questionnaire is a 12-question scale that measures subjective barriers to using a PAP machine. Each question is scored on a scale of 0-1, with a total score possible of 0-12. Greater scores indicate greater difficulty with wearing a PAP machine. Each yes answer can be addressed to improve the patient's use of the PAP.

    Investigators hypothesize that the SAM Clinic intervention will be able to address PAP barriers more effectively compared to usual care. This questionnaire is in the yes/no format. This questionnaire is in the survey that will be completed by the patient.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835702


Contacts
Contact: Joan E Aylor, BA 216-445-1698 aylorj@ccf.org

Sponsors and Collaborators
The Cleveland Clinic
ResMed
Investigators
Principal Investigator: Harneet K Walia, MD The Cleveland Clinic

Publications:

Responsible Party: Harneet Walia, MD, Associate Professor CCLCM, Quality Improvement Officer, Staff, Center for Sleep Disorders, Neurologic Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03835702     History of Changes
Other Study ID Numbers: 19-110
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Harneet Walia, MD, The Cleveland Clinic:
PAP
Group
PAP adherence

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases