PAP Therapy in Patients With Obesity Hypoventilation Syndrome

PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Device: Positive airway pressure (PAP)

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 Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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).	Device: Positive airway pressure (PAP); Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Crete

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2009
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: OHSPAP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No