PAP Therapy in Patients With Obesity Hypoventilation Syndrome

Not Applicable

Completed

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Device: Positive airway pressure (PAP)

• Registration Number: NCT03449641
• Lead Sponsor: University of Crete

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.

Study Timeline

• Study Start: 2009-06-01
• Primary Completion: 2012-06-01
• Study Completion: 2012-06-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effects of positive airway pressure (PAP) therapy on gas exchange	2 years	Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements

Secondary Outcome Measures

Name	Time	Method
Effects of positive airway pressure (PAP) therapy on sleepiness	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	2 years	Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
Effects of positive airway pressure (PAP) therapy on depression	2 years	Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
Effects of positive airway pressure (PAP) therapy on death rate	2 years	Effects of positive airway pressure (PAP) therapy on number of deaths