PAP Therapy in Patients With Obesity Hypoventilation Syndrome

Overview

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).

Full Title of Study: “PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2012

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.

Interventions

  • Device: Positive airway pressure (PAP)
    • Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Effects of positive airway pressure (PAP) therapy on gas exchange
    • Time Frame: 2 years
    • Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements

Secondary Measures

  • Effects of positive airway pressure (PAP) therapy on sleepiness
    • Time Frame: 2 years
    • Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
  • Effects of positive airway pressure (PAP) therapy on quality of life
    • Time Frame: 2 years
    • Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
  • Effects of positive airway pressure (PAP) therapy on depression
    • Time Frame: 2 years
    • Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
  • Effects of positive airway pressure (PAP) therapy on death rate
    • Time Frame: 2 years
    • Effects of positive airway pressure (PAP) therapy on number of deaths

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Crete
  • Provider of Information About this Clinical Study
    • Principal Investigator: Izolde Bouloukaki, Principal Investigator – University of Crete
  • Overall Official(s)
    • Sophia Schiza, MD, PhD, Study Chair, University of Crete

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