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

University of Crete

Status: Completed

Conditions: Sleep Apnea

Treatments: Behavioral: Intensive care; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT02016339

CPAPCOMPL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,836 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,836 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard care

Intensive care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensive care