Validation Study of a Patch-based PSG System

Onera

Status

Invitation-only

Conditions

Sleep Disorder

Treatments

Diagnostic Test: Polysomnography

Study type

Interventional

Funder types

Industry

Identifiers

NCT05310708

CIP_Protocol_Onera_R01

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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