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

NCT02016339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2836

Last updated 2013-12-23

No results posted yet for this study

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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • University of Crete

    lead OTHER

Principal Investigators

  • Sophia E Schiza, MD, PhD · University of Crete

  • Charalampos Mermigkis, MD, PhD · Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece

  • Izolde Bouloukaki, MD, PhD · University of Crete

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2013-06-30
Completion
2013-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016339 on ClinicalTrials.gov