Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Home Respiratory Polygraphy, Standard Polysomnography, Validity, Cost-effectiveness
Brief summary
To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).
Detailed description
To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA). METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Cost-effectiveness variables. ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the Receiver Operating Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.
Interventions
OTHERHome Respiratory Polygraphy (APNIA)
Randomizing to start with home respiratory polygraphy (APNIA)
Randomizing to start with Standard Polysomnography (PSG)
Sponsors
BTI Biotechnology Institute S.L
Instituto de Investigación Sanitaria BIO-ARABA
Hospital Universitario Araba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men and women over 18 years to 75 years old, with clinical suspicion of OSA * Written informed consent signed
Exclusion criteria
* Psycho-Physical inability to perform the study at home * Presence of insomnia or depressive syndrome * Patient with malformation syndromes, Down syndrome and neuromuscular diseases * Cardiovascular, cerebrovascular or respiratory disease exacerbated. * Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | baseline | To assess the diagnostic validity of a home respiratory polygraphy (HRP) compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | baseline and at 6 month | The Epworth Sleepiness Scale (the sum of 8 items score,0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness. |
| STOP-BANG Sleep apnea questionnaire | baseline and at 6 month | Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea. |
| Berlin questionnaire | baseline and at 6 month | The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. |
| Therapeutic decision | 6 month | The concordance of the diagnosis and treatment decision when using clinical findings and data from standard polysomnography (PSG) or home respiratory polygraphy (HRP). |
| Blood pressure | baseline and at 6 month | Blood pressure measurements: systolic blood pressure and diastolic blood pressure |
| Anthropometric variables (Body mass index) | baseline and at 6 month | Body mass index |
| Quality of life (EuroQOL test) | baseline and at 6 month | Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-car, usual activities, pain/discomfort and anxiety/depression), each o wich is defined with three levels of severity, as measured by a Likert scale type (no problems, some problems and many problems or inability to activity). |
| Cost-effectiveness analysis | 6 month | Cost-efficacy evaluation |
Countries
Spain
Outcome results
None listed