Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
1 other identifier
interventional
2,836
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedDecember 23, 2013
December 1, 2013
6 years
November 27, 2013
December 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of intensive intervention on CPAP adherence
24 months
Secondary Outcomes (3)
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 Outcomes (2)
Effect of intensive intervention on hospitalization rate.
24 months
Effect of intensive intervention on withdrawal of CPAP
24 months
Study Arms (2)
Standard Care
ACTIVE COMPARATOR24 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
Intensive care
ACTIVE COMPARATORStandard 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.
Interventions
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.
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
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24993911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sophia E Schiza, MD, PhD
University of Crete
- STUDY DIRECTOR
Charalampos Mermigkis, MD, PhD
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
- PRINCIPAL INVESTIGATOR
Izolde Bouloukaki, MD, PhD
University of Crete
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant family physician, Sleep Medicine subspecialty
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 20, 2013
Study Start
June 1, 2007
Primary Completion
June 1, 2013
Study Completion
October 1, 2013
Last Updated
December 23, 2013
Record last verified: 2013-12