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NCT Number: NCT03449641

PAP Therapy in Patients With Obesity Hypoventilation Syndrome

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).

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Key information

Conditions

Obesity Hypoventilation Syndrome Apnea Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Airway Pressure (PAP)

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2018
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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