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Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard care
Intensive care
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
  • with moderate to severe sleep apnea,
  • no history of previously CPAP therapy and
  • with an above-elementary school education.

Exclusion Criteria:

  • refusal to participate,
  • refusal to CPAP therapy,
  • previous CPAP treatment,
  • central sleep apnoea syndrome,
  • Cheyne-stokes breathing pattern,
  • obesity hypoventilation syndrome,
  • restrictive ventilator syndromes,
  • congestive heart failure,
  • history of life-threatening arrhythmias,
  • cardiomyopathy,
  • long term oxygen therapy,
  • family or personal history of mental illness,
  • with drug or alcohol abuse,
  • severe cognitive impairment,
  • concurrent oncologic diseases and
  • history of narcolepsy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Standard Care

    Intensive care

    Arm Description

    24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy

    Standard group care plus: Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence.

    Outcomes

    Primary Outcome Measures

    Effect of intensive intervention on CPAP adherence

    Secondary Outcome Measures

    Effect of intensive intervention on sleepiness.
    Effect of intensive intervention on mood.
    Effect of intensive intervention on quality of life

    Full Information

    First Posted
    November 27, 2013
    Last Updated
    December 20, 2013
    Sponsor
    University of Crete
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02016339
    Brief Title
    Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
    Official Title
    Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Crete

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.
    Detailed Description
    There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2836 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm Description
    24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy
    Arm Title
    Intensive care
    Arm Type
    Active Comparator
    Arm Description
    Standard group care plus: Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard care
    Intervention Description
    24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive care
    Intervention Description
    Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence
    Primary Outcome Measure Information:
    Title
    Effect of intensive intervention on CPAP adherence
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Effect of intensive intervention on sleepiness.
    Time Frame
    24 months
    Title
    Effect of intensive intervention on mood.
    Time Frame
    24 months
    Title
    Effect of intensive intervention on quality of life
    Time Frame
    24 months
    Other Pre-specified Outcome Measures:
    Title
    Effect of intensive intervention on hospitalization rate.
    Time Frame
    24 months
    Title
    Effect of intensive intervention on withdrawal of CPAP
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria, with moderate to severe sleep apnea, no history of previously CPAP therapy and with an above-elementary school education. Exclusion Criteria: refusal to participate, refusal to CPAP therapy, previous CPAP treatment, central sleep apnoea syndrome, Cheyne-stokes breathing pattern, obesity hypoventilation syndrome, restrictive ventilator syndromes, congestive heart failure, history of life-threatening arrhythmias, cardiomyopathy, long term oxygen therapy, family or personal history of mental illness, with drug or alcohol abuse, severe cognitive impairment, concurrent oncologic diseases and history of narcolepsy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophia E Schiza, MD, PhD
    Organizational Affiliation
    University of Crete
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Charalampos Mermigkis, MD, PhD
    Organizational Affiliation
    Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Izolde Bouloukaki, MD, PhD
    Organizational Affiliation
    University of Crete
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24993911
    Citation
    Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, Michelakis S, Siafakas NM, Schiza SE. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J. 2014 Nov;44(5):1262-74. doi: 10.1183/09031936.00021314. Epub 2014 Jul 3.
    Results Reference
    derived

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    Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance

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