Obesity Hypoventilation Syndrome
Conditions
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.
Interventions
Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
Sponsors
University of Crete
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of positive airway pressure (PAP) therapy on gas exchange | 2 years | Effects of positive airway pressure (PAP) therapy on arterial blood gases measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of positive airway pressure (PAP) therapy on sleepiness | 2 years | Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score |
| Effects of positive airway pressure (PAP) therapy on quality of life | 2 years | Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire |
| Effects of positive airway pressure (PAP) therapy on depression | 2 years | Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire |
| Effects of positive airway pressure (PAP) therapy on death rate | 2 years | Effects of positive airway pressure (PAP) therapy on number of deaths |
Outcome results
None listed