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

Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure Compliance: The Greek Experience

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Behavioral: Standard care; Behavioral: Intensive care

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 Type: Interventional
• Enrollment (Actual): 2836
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Standard care; 24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.
Active Comparator: 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.	Behavioral: Intensive care; Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of intensive intervention on CPAP adherence	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of intensive intervention on sleepiness.	24 months
Effect of intensive intervention on mood.	24 months
Effect of intensive intervention on quality of life	24 months

Other Outcome Measures

Outcome Measure	Time Frame
Effect of intensive intervention on hospitalization rate.	24 months
Effect of intensive intervention on withdrawal of CPAP	24 months

Collaborators and Investigators

• Sponsor: University of Crete
• Investigators: Study Director: Charalampos Mermigkis, MD, PhD, Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 20, 2013

Study Record Updates

• Last Update Posted (Estimate): December 23, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: CPAPCOMPL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No