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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01347398
• Other study ID #: ApneaLink
• Status: Active, not recruiting
• Phase: N/A
• First received: April 18, 2011
• Last updated: February 6, 2013
• Start date: March 2009
• Est. completion date: April 2014

Study information

• Verified date: February 2013
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 815
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• PSG
Sleep study made by PSG (polysomnography)
• MicroMESAM system
Sleep study made by MicroMESAM system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients correctly diagnosed by MicroMESAM (APNEA-LINK)		3 months	No