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

From the registry’s dates

Registered 8 years 8 months after the study started (first participant enrolled Jun 2009, registered Feb 2018).

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

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.

Conditions studied

Obesity Hypoventilation Syndrome

Browse trials for

Obesity Hypoventilation Syndrome 73

In context

Obesity Hypoventilation Syndrome

73 studies on the registry are indexed under Obesity Hypoventilation Syndrome; 10 are open to participants now.

This study's enrollment of 252 is above the median of 40 across 42 interventional studies indexed under Obesity Hypoventilation Syndrome.

Browse Obesity Hypoventilation Syndrome studies →

Lead sponsor

University of Crete is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

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.

What researchers measure

Primary outcomes

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

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
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
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
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

Study locations

No study locations are listed for this record.

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 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2009 to primary completion in Jun 2012, 36 months.

Of 17 interventional studies with no phase under Obesity Hypoventilation Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 22, 2018
First posted: Feb 28, 2018
StartActual: Jun 1, 2009
Primary completionActual: Jun 1, 2012
CompletionActual: Jun 1, 2012
Last update: Mar 1, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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 ↗

Not currently enrolling

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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Discussion

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