PAP Therapy in Patients With Obesity Hypoventilation Syndrome

University of Crete

Status: Completed

Conditions: Obesity Hypoventilation Syndrome

Treatments: Device: Positive airway pressure (PAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03449641

OHSPAP1

Details and patient eligibility

About

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 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.

Enrollment: 252 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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252 participants in 1 patient group

Positive airway pressure (PAP) treatment

Other group

Description:

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

Treatment:

Device: Positive airway pressure (PAP)