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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016339
• Other study ID #: CPAPCOMPL-01
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: December 20, 2013
• Start date: June 2007
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2836
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of intensive intervention on hospitalization rate.		24 months	No
Other	Effect of intensive intervention on withdrawal of CPAP		24 months	No
Primary	Effect of intensive intervention on CPAP adherence		24 months	No
Secondary	Effect of intensive intervention on sleepiness.		24 months	No
Secondary	Effect of intensive intervention on mood.		24 months	No
Secondary	Effect of intensive intervention on quality of life		24 months	No