Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH)

Validity of a Supersimplified Device for Diagnosis of Patients With Suspected Obstructive Sleep Apnoea-hypopnoea (OSAH).

The diagnosis of OSASH requires expensive sleep tests that generate long waiting lists, so we need simplified and rapid diagnostic tools. The ApneaLinkTM, is a device that allows the assessment of respiratory events by measuring the flow ventilation with a nasal cannula connected to a pressure transducer.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: MicroMESAM system; Procedure: PSG

• Study Type: Interventional
• Enrollment (Anticipated): 815
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18 to 75 years of both sexes.
2. clinical suspicion of OSAH defined as subjects with breathing pauses during sleep and / or asphyxiated sounds, with or without excessive daytime sleepiness as measured by the Epworth scale and who have asked for a sleep test to rule out OSAH.
3. Informed consent signed by the patient.

Exclusion Criteria:

1. Place of residence more than 100 km from the hospital.
2. inability to perform psychophysical study at home.
3. cardio-vascular disease, cerebro-vascular or respiratory or acute severe unstable as to preclude the proper conduct of studies at home and / or PSG in the laboratory.
4. Patients with chronic insomnia or recognize sleep less than six hours.
5. Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time).
6. nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MicroMESAM; Sleep study made by MicroMESAM system	Procedure: MicroMESAM system; Sleep study made by MicroMESAM system
ACTIVE_COMPARATOR: PSG; Sleep study made by PSG (polysomnography)	Procedure: PSG; Sleep study made by PSG (polysomnography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)	3 months

Collaborators and Investigators

• Sponsor: Basque Health Service

Publications and helpful links

General Publications

• Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Fortuna AM, Gonzalez-Mangado N, de la Pena M, Aizpuru F, Barbe F, Montserrat JM; Spanish Sleep Network. Efficacy of home single-channel nasal pressure for recommending continuous positive airway pressure treatment in sleep apnea. Sleep. 2015 Jan 1;38(1):13-21. doi: 10.5665/sleep.4316.
• Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Mayos M, Gonzalez-Mangado N, de la Pena M, Aizpuru F, Barbe F, Montserrat JM; Spanish Sleep Network; Larrateguy LD, de Castro JR, Garcia-Ledesma E, Utrabo I, Corral J, Martinez-Null C, Egea C, Cancelo L, Garcia-Diaz E, Carmona-Bernal C, Sanchez-Armengol A, Fortuna AM, Miralda RM, Troncoso MF, Monica G, Martinez-Martinez M, Cantalejo O, Pierola J, Vigil L, Embid C, Del Mar Centelles M, Prieto TR, Rojo B, Vanesa L. Effectiveness of home single-channel nasal pressure for sleep apnea diagnosis. Sleep. 2014 Dec 1;37(12):1953-61. doi: 10.5665/sleep.4248.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): April 1, 2014

Study Registration Dates

• First Submitted: April 18, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (ESTIMATE): May 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Diagnosis; Blood pressure; Body mass index; Sleep apnoea; Breath analysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: ApneaLink