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CompletedNCT03449641Updated Mar 1, 2018

PAP Therapy in Patients With Obesity Hypoventilation Syndrome

An interventional study of Positive airway pressure (PAP) in Obesity Hypoventilation Syndrome, sponsored by University of Crete. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by University of Crete · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Obesity Hypoventilation Syndrome
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
252 participants (actual)

Study arms

  • Other
    Positive airway pressure (PAP) treatment

    Positive airway pressure (PAP),which reverses upper airway obstruction, is effective in the majority of patients with stable obesity hypoventilation syndrome (OHS).

    Device: Positive airway pressure (PAP)

Interventions

  • DevicePositive airway pressure (PAP)

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

05

What researchers measure

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

    Time frame: 2 years

Secondary outcomes

  1. Effects of positive airway pressure (PAP) therapy on sleepiness

    Effects of positive airway pressure (PAP) therapy on epwoth Sleepiness scale score

    Time frame: 2 years

  2. Effects of positive airway pressure (PAP) therapy on quality of life

    Effects of positive airway pressure (PAP) therapy on Short Form -36 questionnaire

    Time frame: 2 years

  3. Effects of positive airway pressure (PAP) therapy on depression

    Effects of positive airway pressure (PAP) therapy on Beck Depression Inventory questionnaire

    Time frame: 2 years

  4. Effects of positive airway pressure (PAP) therapy on death rate

    Effects of positive airway pressure (PAP) therapy on number of deaths

    Time frame: 2 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 30176976 ↗
08

Registry details

Key details

Study ID
NCT03449641
Lead sponsor
University of Crete
Responsible party
Izolde Bouloukaki (Principal Investigator, University of Crete) — Principal investigator
First posted
Feb 28, 2018
Start date
Jun 1, 2009
Primary completion
Jun 1, 2012
Completion
Jun 1, 2012
Last update
Mar 1, 2018

Study contacts

Sophia Schiza, MD, PhD
study chair · University of Crete

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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