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NCT Number: NCT03571477

Sleep Apnea : Diagnosis and Monitoring

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble-Alpes

La Tronche, Isère, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApneaBand

Device

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

Primary outcomes

  1. Performance of the ApneaBand to detect sleep apnea

    Time frame: 3 days

    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

Secondary outcomes

  1. Performance of the ApneaBand to mesure the apnea severity

    Time frame: 3 days

    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

  2. External reproductibility of AHI measurement by the ApneaBand

    Time frame: 3 days

    Reproducibility between AHI from polysomnography and ApneaBand

  3. Internal reproductibility of AHI measurement by the ApneaBand

    Time frame: 3 days

    Reproducibility between different AHI mesures from ApneaBand

  4. ApneaBand algorith validation for AHI measurement

    Time frame: 3 days

    External validation of the ApneaBand algorithm

  5. Sleep stage detection by ApneaBand

    Time frame: 3 days

    To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages

  6. Skin tone variability

    Time frame: 3 days

    To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom
  • AIRFAN
  • Commissariat A L'energie Atomique

Registry information

Acronym: ApneaBand

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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