Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Behavioral: Standard care; Behavioral: Intensive care

• Registration Number: NCT02016339
• Lead Sponsor: University of Crete

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.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2013-06
• Study Completion: 2013-10
• Study First Submitted: 2013-11-27
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-20
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2836

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard care	24 hour consultation telephone line to the sleep nurses will be open for the patients. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy
Intensive care	Intensive care	Standard group care plus: Involvement of the patient's partner or family. Extra education on sleep apnea syndrome and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence.

Primary Outcome Measures

Name	Time	Method
Effect of intensive intervention on CPAP adherence	24 months

Secondary Outcome Measures

Name	Time	Method
Effect of intensive intervention on quality of life	24 months
Effect of intensive intervention on sleepiness.	24 months
Effect of intensive intervention on mood.	24 months