PAP Therapy in Patients With Obesity Hypoventilation Syndrome
Primary Purpose
Obesity Hypoventilation Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Positive airway pressure (PAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Positive airway pressure (PAP) treatment
Arm Description
Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).
Outcomes
Primary Outcome Measures
Effects of positive airway pressure (PAP) therapy on gas exchange
Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements
Secondary Outcome Measures
Effects of positive airway pressure (PAP) therapy on sleepiness
Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
Effects of positive airway pressure (PAP) therapy on quality of life
Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
Effects of positive airway pressure (PAP) therapy on depression
Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
Effects of positive airway pressure (PAP) therapy on death rate
Effects of positive airway pressure (PAP) therapy on number of deaths
Full Information
NCT ID
NCT03449641
First Posted
February 22, 2018
Last Updated
February 28, 2018
Sponsor
University of Crete
1. Study Identification
Unique Protocol Identification Number
NCT03449641
Brief Title
PAP Therapy in Patients With Obesity Hypoventilation Syndrome
Official Title
PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2009 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive airway pressure (PAP) treatment
Arm Type
Other
Arm Description
Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).
Intervention Type
Device
Intervention Name(s)
Positive airway pressure (PAP)
Intervention Description
Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
Primary Outcome Measure Information:
Title
Effects of positive airway pressure (PAP) therapy on gas exchange
Description
Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Effects of positive airway pressure (PAP) therapy on sleepiness
Description
Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score
Time Frame
2 years
Title
Effects of positive airway pressure (PAP) therapy on quality of life
Description
Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire
Time Frame
2 years
Title
Effects of positive airway pressure (PAP) therapy on depression
Description
Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire
Time Frame
2 years
Title
Effects of positive airway pressure (PAP) therapy on death rate
Description
Effects of positive airway pressure (PAP) therapy on number of deaths
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Schiza, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
30176976
Citation
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.
Results Reference
derived
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PAP Therapy in Patients With Obesity Hypoventilation Syndrome
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