Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea (APNiA)

Hospital Universitario Araba

Status: Completed

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Other: Home Respiratory Polygraphy (APNIA); Other: Standard Polysomnography (PSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03415633

2015-026

Details and patient eligibility

About

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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251 participants in 2 patient groups

Diagnostic Randomizing

Active Comparator group

Description:

Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)

Treatment:

Other: Home Respiratory Polygraphy (APNIA)

Other: Standard Polysomnography (PSG)

Other: Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (APNIA)

Therapeutic Randomizing

Active Comparator group

Description:

Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)

Treatment:

Other: Home Respiratory Polygraphy (APNIA)

Other: Standard Polysomnography (PSG)

Other: Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (APNIA)