Clinical trial NCT03415633: Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
Official title: Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Home Respiratory Polygraphy
Standard Polysomnography
Validity
Cost-effectiveness
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: BTI Biotechnology Institute S.L
name: Instituto de Investigación Sanitaria BIO-ARABA
First posted: 2018-01-30
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: baseline
Secondary outcomes:
measure: Therapeutic decision
timeFrame: 6 month
measure: Epworth Sleepiness Scale
timeFrame: baseline and at 6 month
measure: STOP-BANG Sleep apnea questionnaire
timeFrame: baseline and at 6 month
measure: Berlin questionnaire
timeFrame: baseline and at 6 month
measure: Cost-effectiveness analysis
timeFrame: 6 month
measure: Blood pressure
timeFrame: baseline and at 6 month
measure: Anthropometric variables (Body mass index)
timeFrame: baseline and at 6 month
measure: Quality of life (EuroQOL test)
timeFrame: baseline and at 6 month
Other outcomes:
Locations:
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Araba
Study officials:
affiliation: Hospital Universitario Araba
name: Joaquin Duran-Cantolla
role: STUDY_DIRECTOR
affiliation: BTI Technology Institute SL
name: Eduardo Anitua-Aldecoa
role: PRINCIPAL_INVESTIGATOR
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