PAP Therapy in Patients With Obesity Hypoventilation Syndrome

University of Crete252 enrolled

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

252

Conditions

Obesity Hypoventilation Syndrome

Interventions

Positive airway pressure (PAP)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Effects of positive airway pressure (PAP) therapy on gas exchange

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

Time frame: 2 years

Secondary Outcomes

Effects of positive airway pressure (PAP) therapy on sleepiness

Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score

Time frame: 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

Time frame: 2 years

Effects of positive airway pressure (PAP) therapy on depression

Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire

Time frame: 2 years

Effects of positive airway pressure (PAP) therapy on death rate

Effects of positive airway pressure (PAP) therapy on number of deaths

Time frame: 2 years

Data from ClinicalTrials.gov

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