Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
1 other identifier
interventional
66
1 country
1
Brief Summary
The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedJuly 27, 2010
October 1, 2009
1.5 years
October 7, 2009
July 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in compliance among the three different strategies, measured by CPAP hours of use
six months follow-up
Secondary Outcomes (1)
costs of the three different strategies, including number of visits and phone calls that were necessary to improve compliance and additional diagnostic tests.
six months follow-up
Study Arms (3)
Domiciliary group
ACTIVE COMPARATORIn this group OSA diagnosis was performed at patient's home by mean of non-attended RP. All follow-up visits were conducted by a trained nurse in patient's home.
Hospital Group
ACTIVE COMPARATORIn this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician
Mixed Group
ACTIVE COMPARATORIn this group diagnosis was made by home RP, and follow-up at hospital
Interventions
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
Eligibility Criteria
You may qualify if:
- Patients with high probability of OSA, defined by two or more of :
- daytime sleepiness
- snoring
- recognized apnoeic episodes
- associating obesity and / or hypertension
You may not qualify if:
- Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias)
- Patients treated with CPAP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital San Juan de Alicante
San Juan, Alicante, 03550, Spain
Related Publications (1)
Andreu AL, Chiner E, Sancho-Chust JN, Pastor E, Llombart M, Gomez-Merino E, Senent C, Barbe F. Effect of an ambulatory diagnostic and treatment programme in patients with sleep apnoea. Eur Respir J. 2012 Feb;39(2):305-12. doi: 10.1183/09031936.00013311. Epub 2011 Jun 30.
PMID: 21719490DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eusebi Chiner Vives, MD
Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 27, 2009
Study Start
June 1, 2003
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
July 27, 2010
Record last verified: 2009-10