Sleep Apnea : Diagnosis and Monitoring

NCT03571477 | Completed

• 1 other identifier: 38RC18.010
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apnea diagnosis; Sleep apnea monitoring

Outcome Measures

Primary Outcomes (1)

• Performance of the ApneaBand to detect sleep apnea

  Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG

  3 days

Secondary Outcomes (6)

• Performance of the ApneaBand to mesure the apnea severity

  3 days

• External reproductibility of AHI measurement by the ApneaBand

  3 days

• Internal reproductibility of AHI measurement by the ApneaBand

  3 days

• ApneaBand algorith validation for AHI measurement

  3 days

• Sleep stage detection by ApneaBand

  3 days

Interventions

ApneaBand DEVICE

Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients with OSA and not treated for that * Non apneic subjects or unknown apneic subjects wishing to explore their sleep * Different skin tones from Fitzpatrick's phototypes I to VI.

You may qualify if:

• Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
• Non apneic person (Berlin score = 0 or 1)
• Person be able to use the personal health monitoring device ApneaBand
• Be legally able to give consent
• Person affiliated to social security

You may not qualify if:

• Patient already treated for OSA
• Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
• Being unable to understand and to follow recommendations for the study due to cognition or language problems
• Pregnant women, feeding and parturient
• Person under administrative or judicial control, or who is protected under the act
• Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator
• AIRFAN: collaborator
• AGIR à Dom: collaborator

Study Sites (1)

Chu Grenoble-Alpes

La Tronche, Isère, 38700, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis PEPIN, Pr

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 27, 2018
• Study Start: June 15, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

FR (1)