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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03449641
Other study ID # OHSPAP1
Secondary ID
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
Health authority
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.

Study Design


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
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