Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.
Diagnosis, Cost and Therapeutic Decision-Making of Home Respiratory Polygraphy for Patients Without High Suspicion of OSA or With Comorbidity - Hospital Polysomnography in Comparison With Three Nights of Home Respiratory Polygraphy
1 other identifier
interventional
56
1 country
1
Brief Summary
Study Objectives: Obstructive sleep apnea (OSA) diagnosis using simplified methods such as home respiratory polygraphy (HRP) is only recommended in patients with a high pre-test probability. The aim is to determine the diagnostic efficacy, therapeutic decision-making and costs of OSA diagnosis using PSG or three consecutive studies of HRP in patients with mild-moderate suspicion of sleep apnea or with co-morbidity that can mask OSA symptoms. Design and Setting: Randomized, blinded, crossover study of three nights of HRP (3N-HRP) vs. PSG. The diagnostic efficacy was evaluated with ROC curves. Therapeutic decisions to assess concordance between the two different approaches were analyzed by sleep physicians and respiratory physicians (staff and residents) using agreement level and kappa coefficient. The costs of each diagnostic strategy were considered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
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
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 24, 2015
September 1, 2013
8 months
March 20, 2013
March 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic decision based on full PSG or respiratory polygraphy data (3 nights)
The investigators want to compare the clinical decision between full PSG (CPAP or NO CPAP)and respiratory polygraphy performed during 3 nights (CPAP or NO CPAP) when there is discrepancy between symptoms and data from respiratory polygraphy.
Three months
Secondary Outcomes (2)
Apnea and Hypopnea Index (AHI)
3 months
Cost-effectiveness analysis
3 months
Study Arms (2)
HRP-PSG
EXPERIMENTALFirst performance three nights of HRP and following one night of laboratory PSG
PSG-HRP
EXPERIMENTALFirst perform laboratory PSG and following three nights of HRP
Interventions
Eligibility Criteria
You may qualify if:
- Patients with low or medium suspicion of Sleep Apnea
- Patients with notorious comorbidity
- Age between 18 and 75 years
- Capability to fill in written questionnaires
You may not qualify if:
- Patients with high suspicion of sleep apnea
- Serious heart disease, resistant systemic hypertension, Suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders and restless leg syndrome.
- Patients with diagnosis of SAHS
- Lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
Related Publications (1)
Guerrero A, Embid C, Isetta V, Farre R, Duran-Cantolla J, Parra O, Barbe F, Montserrat JM, Masa JF. Management of sleep apnea without high pretest probability or with comorbidities by three nights of portable sleep monitoring. Sleep. 2014 Aug 1;37(8):1363-73. doi: 10.5665/sleep.3932.
PMID: 25083017DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD. Pulmonary
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 28, 2013
Study Start
February 1, 2012
Primary Completion
October 1, 2012
Study Completion
June 1, 2013
Last Updated
March 24, 2015
Record last verified: 2013-09