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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea

Intervention / Treatment
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* Behavioral: Standard care
* Behavioral: Intensive care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>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<br>* 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.<br>|
| Active Comparator: Intensive care<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |