NCT01347398

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
815

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

4.8 years

First QC Date

April 18, 2011

Last Update Submit

February 6, 2013

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apnoeaDiagnosisBlood pressureBody mass indexBreath analysis

Outcome Measures

Primary Outcomes (1)

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

    3 months

Study Arms (2)

MicroMESAM

EXPERIMENTAL

Sleep study made by MicroMESAM system

Procedure: MicroMESAM system

PSG

ACTIVE COMPARATOR

Sleep study made by PSG (polysomnography)

Procedure: PSG

Interventions

PSGPROCEDURE

Sleep study made by PSG (polysomnography)

PSG
MicroMESAM systemPROCEDURE

Sleep study made by MicroMESAM system

MicroMESAM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25325508DERIVED

  • 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.

    PMID: 25325484DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesDisease

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 18, 2011

First Posted

May 4, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

February 7, 2013

Record last verified: 2013-02