Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
NCT ID: NCT02016339
Last Updated: 2013-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2836 participants
INTERVENTIONAL
2007-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Care
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
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. 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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* with moderate to severe sleep apnea,
* no history of previously CPAP therapy and
* with an above-elementary school education.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University of Crete
OTHER
Responsible Party
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Izolde Bouloukaki
Consultant family physician, Sleep Medicine subspecialty
Principal Investigators
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Sophia E Schiza, MD, PhD
Role: STUDY_CHAIR
University of Crete
Charalampos Mermigkis, MD, PhD
Role: STUDY_DIRECTOR
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Izolde Bouloukaki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Crete
References
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Bouloukaki I, Giannadaki K, Mermigkis C, Tzanakis N, Mauroudi E, Moniaki V, Michelakis S, Siafakas NM, Schiza SE. Intensive versus standard follow-up to improve continuous positive airway pressure compliance. Eur Respir J. 2014 Nov;44(5):1262-74. doi: 10.1183/09031936.00021314. Epub 2014 Jul 3.
Other Identifiers
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CPAPCOMPL-01
Identifier Type: -
Identifier Source: org_study_id