Sleep Apnea : Diagnosis and Monitoring

Obstructive Sleep Apnea Clinical Trial

— ApneaBand  

Official title:

Sleep Apnea : Diagnosis and Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571477
• Other study ID #: 38RC18.010
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: December 17, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.

40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).

Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 in exclusion period for another study

• Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Chu Grenoble-Alpes	La Tronche	Isère

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom, AIRFAN, Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Performance of the ApneaBand to mesure the apnea severity	Performance of the ApneaBand device in detecting sleep apnea according to its severity (2 pre-specified thresholds of AHI: > 5 and = 30), in comparison with PSG	3 days
Secondary	External reproductibility of AHI measurement by the ApneaBand	Reproducibility between AHI from polysomnography and ApneaBand	3 days
Secondary	Internal reproductibility of AHI measurement by the ApneaBand	Reproducibility between different AHI mesures from ApneaBand	3 days
Secondary	ApneaBand algorith validation for AHI measurement	External validation of the ApneaBand algorithm	3 days
Secondary	Sleep stage detection by ApneaBand	To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages	3 days
Secondary	Skin tone variability	To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones	3 days