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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Therapeutic decision based on full PSG or respiratory polygraphy data (3 nights)
Study Overview
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.
Detailed Description
Study subjects The study population consisted of subjects who were referred to the sleep unit of the Clínic Hospital, Barcelona, Spain, or the San Pedro de Alcantara Hospital, Cáceres, Spain, with a mild-moderate clinical suspicion of OSA or with notorious co-morbidity that induced frequent symptoms which mimicked those of OSA or could reduce sleep time.
The inclusion criteria were: a) Patients with snoring and/or some observed apneas during sleep. b) Epworth scale less than 15. c) Subjects with notorious co-morbidity. d) Age between 18 and 75 years.
The exclusion criteria were as follows: high suspicion of sleep apnea (heavy snoring, breathing pauses and somnolence that makes social life or working difficult, without any other causes of hypersomnia); diagnosis of OSA; severe heart disease or resistant systemic hypertension; suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders, and restless leg syndrome; psychophysical disability that would impede the application of the home polygraphy device or major co-morbidity (unstable heart disease, unstable pulmonary disease or disabling stroke); and lack of informed consent for the protocol approved by the ethics committees of the two centres.
Protocol We compared 3N-HRP with laboratory-standard PSG in randomized patients who met the inclusion and exclusion criteria. The subjects were studied on a random basis for one night in a sleep lab (standard PSG) and for three consecutive nights with HRP. Once the first test had started, the second test was scheduled for within the following two days. PSG and HRP were scored separately and the technicians and physicians were blinded to any identifying information about the patients, as well as to any previous results.
Measurements Clinical data: Gender, age, weight, height, body mass index (BMI), waist-hip ratio, neck circumference, systolic and diastolic blood pressure, and alcohol intake measured as ≤ 60 gr/day or > 60 gr/day, and tobacco consumption.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
HRP-PSG
First performance three nights of HRP and following one night of laboratory PSG
Intervention: Home Respiratory Polygraphy (Device)
HRP-PSG
First performance three nights of HRP and following one night of laboratory PSG
Intervention: Standard Polysomnography (Device)
PSG-HRP
First perform laboratory PSG and following three nights of HRP
Intervention: Home Respiratory Polygraphy (Device)
PSG-HRP
First perform laboratory PSG and following three nights of HRP
Intervention: Standard Polysomnography (Device)
Outcomes
Primary Outcomes
Therapeutic decision based on full PSG or respiratory polygraphy data (3 nights)
Time Frame: Three months
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.
Secondary Outcomes
- Apnea and Hypopnea Index (AHI)(3 months)
- Cost-effectiveness analysis(3 months)
Investigators
Jose M. Montserrat
MD PhD. Pulmonary
Hospital Clinic of Barcelona
