Clinical trial NCT02016339: Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Official title: Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 2836
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

Detailed description: There is limited data concerning long-term randomized clinical trials proving the long-term efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP initiation.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed obstructive sleep apnea syndrome by polysomnography according to standard criteria,
* with moderate to severe sleep apnea,
* no history of previously CPAP therapy and
* with an above-elementary school education.

Exclusion Criteria:

* refusal to participate,
* refusal to CPAP therapy,
* previous CPAP treatment,
* central sleep apnoea syndrome,
* Cheyne-stokes breathing pattern,
* obesity hypoventilation syndrome,
* restrictive ventilator syndromes,
* congestive heart failure,
* history of life-threatening arrhythmias,
* cardiomyopathy,
* long term oxygen therapy,
* family or personal history of mental illness,
* with drug or alcohol abuse,
* severe cognitive impairment,
* concurrent oncologic diseases and
* history of narcolepsy.

Primary outcomes:
measure: Effect of intensive intervention on CPAP adherence
timeFrame: 24 months
Secondary outcomes:
measure: Effect of intensive intervention on sleepiness.
timeFrame: 24 months
measure: Effect of intensive intervention on mood.
timeFrame: 24 months
measure: Effect of intensive intervention on quality of life
timeFrame: 24 months
Other outcomes:
measure: Effect of intensive intervention on hospitalization rate.
timeFrame: 24 months
measure: Effect of intensive intervention on withdrawal of CPAP
timeFrame: 24 months
Locations:
Study officials:
affiliation: University of Crete
name: Sophia E Schiza, MD, PhD
role: STUDY_CHAIR
affiliation: Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
name: Charalampos Mermigkis, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Crete
name: Izolde Bouloukaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, Michelakis S, Siafakas NM, Schiza SE. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J. 2014 Nov;44(5):1262-74. doi: 10.1183/09031936.00021314. Epub 2014 Jul 3.