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PAP Therapy in Patients With Obesity Hypoventilation Syndrome

Primary Purpose

Obesity Hypoventilation Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positive airway pressure (PAP)
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Hypoventilation Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged between 18 and 80 years
  • Obesity hypoventilation syndrome diagnosis (OHS)
  • clinically stable for at least 4 weeks prior to the enrolmenT
  • above-elementary school education.

Exclusion Criteria:

  • refusal to participate
  • refusal of PAP therapy
  • central sleep apnea syndromes
  • restrictive ventilation syndromes
  • severe congestive heart failure
  • a history of life-threatening arrhythmias
  • severe cardiomyopathy
  • significant chronic kidney disease
  • untreated hypothyroidism
  • family or personal history of mental illness
  • drug or alcohol abuse
  • sedative use
  • severe cognitive impairment
  • concurrent oncological diseases
  • history of narcolepsy or restless legs syndrome.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Positive airway pressure (PAP) treatment

    Arm Description

    Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).

    Outcomes

    Primary Outcome Measures

    Effects of positive airway pressure (PAP) therapy on gas exchange
    Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements

    Secondary Outcome Measures

    Effects of positive airway pressure (PAP) therapy on sleepiness
    Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
    Effects of positive airway pressure (PAP) therapy on quality of life
    Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
    Effects of positive airway pressure (PAP) therapy on depression
    Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
    Effects of positive airway pressure (PAP) therapy on death rate
    Effects of positive airway pressure (PAP) therapy on number of deaths

    Full Information

    First Posted
    February 22, 2018
    Last Updated
    February 28, 2018
    Sponsor
    University of Crete
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03449641
    Brief Title
    PAP Therapy in Patients With Obesity Hypoventilation Syndrome
    Official Title
    PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2009 (Actual)
    Primary Completion Date
    June 1, 2012 (Actual)
    Study Completion Date
    June 1, 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS).
    Detailed Description
    Various forms of positive airway pressure (PAP) therapy are effective in providing short and long-term benefits in these patients with or without obstructive sleep apnea (OSA). However, there are limited data concerning the impact of long-term effects of PAP therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA. Therefore we aimed to assess the role of different levels of compliance and long-term effects of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients with OHS, two year after PAP initiation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity Hypoventilation Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    252 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Positive airway pressure (PAP) treatment
    Arm Type
    Other
    Arm Description
    Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).
    Intervention Type
    Device
    Intervention Name(s)
    Positive airway pressure (PAP)
    Intervention Description
    Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
    Primary Outcome Measure Information:
    Title
    Effects of positive airway pressure (PAP) therapy on gas exchange
    Description
    Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Effects of positive airway pressure (PAP) therapy on sleepiness
    Description
    Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
    Time Frame
    2 years
    Title
    Effects of positive airway pressure (PAP) therapy on quality of life
    Description
    Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
    Time Frame
    2 years
    Title
    Effects of positive airway pressure (PAP) therapy on depression
    Description
    Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
    Time Frame
    2 years
    Title
    Effects of positive airway pressure (PAP) therapy on death rate
    Description
    Effects of positive airway pressure (PAP) therapy on number of deaths
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged between 18 and 80 years Obesity hypoventilation syndrome diagnosis (OHS) clinically stable for at least 4 weeks prior to the enrolmenT above-elementary school education. Exclusion Criteria: refusal to participate refusal of PAP therapy central sleep apnea syndromes restrictive ventilation syndromes severe congestive heart failure a history of life-threatening arrhythmias severe cardiomyopathy significant chronic kidney disease untreated hypothyroidism family or personal history of mental illness drug or alcohol abuse sedative use severe cognitive impairment concurrent oncological diseases history of narcolepsy or restless legs syndrome.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophia Schiza, MD, PhD
    Organizational Affiliation
    University of Crete
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30176976
    Citation
    Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study. J Clin Sleep Med. 2018 Sep 15;14(9):1539-1550. doi: 10.5664/jcsm.7332.
    Results Reference
    derived

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    PAP Therapy in Patients With Obesity Hypoventilation Syndrome

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