PAP Therapy in Patients With Obesity Hypoventilation Syndrome

NCT ID: NCT03449641

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-01
• Study Completion Date: 2012-06-01

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.

Conditions

Obesity Hypoventilation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive airway pressure (PAP) treatment

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

Group Type: OTHER

Positive airway pressure (PAP)

Intervention Type: DEVICE

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

Interventions

Positive airway pressure (PAP)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

References

Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study. J Clin Sleep Med. 2018 Sep 15;14(9):1539-1550. doi: 10.5664/jcsm.7332.

Reference Type: DERIVED

PMID: 30176976 (View on PubMed)

Other Identifiers

OHSPAP1

Identifier Type: -

Identifier Source: org_study_id