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

Primary Purpose

Obstructive Sleep Apnea

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

PSG

MicroMESAM system

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Sleep apnoea, Diagnosis, Blood pressure, Body mass index, Breath analysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients 18 to 75 years of both sexes.
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.
Informed consent signed by the patient.

Exclusion Criteria:

Place of residence more than 100 km from the hospital.
inability to perform psychophysical study at home.
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.
Patients with chronic insomnia or recognize sleep less than six hours.
Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time).
nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MicroMESAM

PSG

Arm Description

Sleep study made by MicroMESAM system

Sleep study made by PSG (polysomnography)

Outcomes

Primary Outcome Measures

Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)

Secondary Outcome Measures

Full Information

NCT ID

NCT01347398

First Posted

April 18, 2011

Last Updated

February 6, 2013

Sponsor

Basque Health Service

1. Study Identification

Unique Protocol Identification Number

NCT01347398

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Basque Health Service

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Sleep apnoea, Diagnosis, Blood pressure, Body mass index, Breath analysis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

815 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MicroMESAM

Arm Type

Experimental

Arm Description

Sleep study made by MicroMESAM system

Arm Title

PSG

Arm Type

Active Comparator

Arm Description

Sleep study made by PSG (polysomnography)

Intervention Type

Procedure

Intervention Name(s)

PSG

Intervention Description

Sleep study made by PSG (polysomnography)

Intervention Type

Procedure

Intervention Name(s)

MicroMESAM system

Intervention Description

Sleep study made by MicroMESAM system

Primary Outcome Measure Information:

Title

Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients 18 to 75 years of both sexes. 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. Informed consent signed by the patient. Exclusion Criteria: Place of residence more than 100 km from the hospital. inability to perform psychophysical study at home. 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. Patients with chronic insomnia or recognize sleep less than six hours. Patients with depression (both point 4 and 5 are the potential causes of false negatives in a PR for lack of sufficient sleep time). nasal obstruction complete or nearly complete, which prevents obtaining a quality signal with MicroMESAM

12. IPD Sharing Statement

Citations:

PubMed Identifier

25325508

Citation

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.

Results Reference

derived

PubMed Identifier

25325484

Citation

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.

Results Reference

derived

Learn more about this trial

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

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