Clinical trial NCT05310708: Validation Study of a Patch-based PSG System
Official title: Validation Study of a Patch-based PSG System
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: Onera BV
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a study that qualifies as "other clinical investigation" under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are substantially equivalent to physiological systems recorded by traditional PSG systems. Furthermore, the study aims to identify the proportion of users who can successfully perform an overnight Onera STS study in an unsupervised home setting. The Onera STS will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Either referral for a suspected sleep disorder requiring a sleep diagnostic study, or,
* An already diagnosed sleep disorder requiring a planned follow-up PSG.

Exclusion Criteria:

* Inability to provide informed consent
* History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
* Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
* Has an implanted cardiac stimulator or diaphragmatic pacer
* Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
* Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device

Primary outcomes:
measure: EOG left
timeFrame: 1 year
measure: EOG right
timeFrame: 1 year
measure: EEG left
timeFrame: 1 year
measure: EEG right
timeFrame: 1 year
measure: EMG left
timeFrame: 1 year
measure: EMG right
timeFrame: 1 year
measure: SpO2
timeFrame: 1 year
measure: ECG
timeFrame: 1 year
measure: BioZ Flow
timeFrame: 1 year
measure: BioZ Effort
timeFrame: 1 year
measure: Activity
timeFrame: 1 year
measure: Snoring
timeFrame: 1 year
measure: Body Position
timeFrame: 1 year
measure: Nasal Cannula Flow
timeFrame: 1 year
measure: EMG Leg
timeFrame: 1 year
Secondary outcomes:
measure: Total Sleep Time
timeFrame: 1 year
measure: Time In Bed
timeFrame: 1 year
measure: SOL
timeFrame: 1 year
measure: Wake Time
timeFrame: 1 year
measure: Time in N1
timeFrame: 1 year
measure: Time in N2
timeFrame: 1 year
measure: Time in N3
timeFrame: 1 year
measure: Time in REM
timeFrame: 1 year
measure: Time in NREM
timeFrame: 1 year
measure: REM
timeFrame: 1 year
measure: NREM
timeFrame: 1 year
measure: REM Onset Latency
timeFrame: 1 year
measure: WASO
timeFrame: 1 year
measure: AI
timeFrame: 1 year
measure: AHI
timeFrame: 1 year
measure: SpO2
timeFrame: 1 year
measure: ODI
timeFrame: 1 year
measure: HR
timeFrame: 1 year
measure: Set-up Time PSG (not applicable for application in unsupervised home setting)
timeFrame: 1 year
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: American Sleep Clinic
state: Frankfurt Am Main
city: Blaubeuren
country: Germany
facility: Schlaf- u. Beatmungszentrum Ulm/Blaubeuren
city: Essen
country: Germany
facility: Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte
city: Hagen
country: Germany
facility: VAMED Klinik Hagen-Ambrock
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg
city: Solingen
country: Germany
facility: Krankenhaus Bethanien
Study officials:
affiliation: Principal Investigator
name: Hartmut Schneider
role: PRINCIPAL_INVESTIGATOR
References: