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Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

Primary Purpose

Sleep Apnea (Disorder)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep apnea diagnosis
Sponsored by
CIDELEC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea (Disorder)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with suspected obstructive sleep apnea

Exclusion Criteria:

  • Lung infection
  • Insomnia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Evaluation of a disposable sound sensor for recording respiration during sleep

    Arm Description

    PneaVoX sensor, CIDELEC

    Outcomes

    Primary Outcome Measures

    Analyzable signal time
    Percentage of the analyzable signal duration compared to the total recorded signal duration

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2022
    Last Updated
    February 28, 2022
    Sponsor
    CIDELEC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05272449
    Brief Title
    Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
    Official Title
    Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 28, 2022 (Anticipated)
    Primary Completion Date
    April 28, 2022 (Anticipated)
    Study Completion Date
    April 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CIDELEC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea (Disorder)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Evaluation of a disposable sound sensor for recording respiration during sleep
    Arm Type
    Experimental
    Arm Description
    PneaVoX sensor, CIDELEC
    Intervention Type
    Device
    Intervention Name(s)
    Sleep apnea diagnosis
    Intervention Description
    Split-night
    Primary Outcome Measure Information:
    Title
    Analyzable signal time
    Description
    Percentage of the analyzable signal duration compared to the total recorded signal duration
    Time Frame
    One night

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with suspected obstructive sleep apnea Exclusion Criteria: Lung infection Insomnia

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

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