PAP Therapy in Patients With Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome Clinical Trial

Official title:

PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449641
• Other study ID #: OHSPAP1
• Status: Completed
• Phase: N/A
• First received: February 22, 2018
• Last updated: February 28, 2018
• Start date: June 1, 2009
• Est. completion date: June 1, 2012

Study information

• Verified date: February 2018
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: June 1, 2012
• Est. primary completion date: June 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effects of positive airway pressure (PAP) therapy on sleepiness	Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score	2 years
Secondary	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
Secondary	Effects of positive airway pressure (PAP) therapy on depression	Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire	2 years
Secondary	Effects of positive airway pressure (PAP) therapy on death rate	Effects of positive airway pressure (PAP) therapy on number of deaths	2 years