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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02016339

Enrollment

2836

Registered

2013-12-20

Start date

2007-06-30

Completion date

2013-10-31

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALIntensive 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Effect of intensive intervention on CPAP adherence	24 months

Secondary

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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026