PAP Therapy in Patients With Obesity Hypoventilation Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome

Conditions
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Obesity Hypoventilation Syndrome

Intervention / Treatment
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* Device: Positive airway pressure (PAP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Positive airway pressure (PAP) treatment<br>Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS). | Device: Positive airway pressure (PAP)<br>* Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of positive airway pressure (PAP) therapy on gas exchange | Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements | 2 years | 

Secondary Outcome Measures

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