PAP Therapy in Patients With Obesity Hypoventilation Syndrome
PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
1 other identifier
interventional
252
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedMarch 1, 2018
February 1, 2018
3 years
February 22, 2018
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Effects of positive airway pressure (PAP) therapy on sleepiness
2 years
Effects of positive airway pressure (PAP) therapy on quality of life
2 years
Effects of positive airway pressure (PAP) therapy on depression
2 years
Effects of positive airway pressure (PAP) therapy on death rate
2 years
Study Arms (1)
Positive airway pressure (PAP) treatment
OTHERPositive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).
Interventions
Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30176976DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sophia Schiza, MD, PhD
University of Crete
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
June 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 1, 2018
Record last verified: 2018-02