search
Back to results

Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study

Primary Purpose

Snoring

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Forrest Snoring device
Sponsored by
GE Sleeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Snoring

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The patient age range : 20-70 years old.
  • The patient / legal guardian able and willing to sign conscious written agreement.
  • The patient / legal guardian able and willing to comply with the study protocol.
  • The patient is suffering from snoring.
  • The patient underwent a sleep study over the last year.

Exclusion Criteria:

  • The patient suffers from sleep apnea that requires CPAP treatment: more than 15 AHI per hour in a sleep study or due to significant background diseases.
  • Patient less than 20 years old.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    one night with the device and one night without the device.

    Arm Description

    The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.

    Outcomes

    Primary Outcome Measures

    Difference between the two following parameters: (1) Total time of snoring during sleep with the device ("Forest") (2) Total time of snoring during sleep without the device. Resulting value is in minutes.

    Secondary Outcome Measures

    Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB
    Number of obstructive events during sleep. Resulting value is an absolute number.
    Difference between the two following parameters: (1) Average oxygen saturation level with the device ("Forest") (2) Average oxygen saturation level without the device. Resulting value is in percents (%).
    Total time during which the oxygen saturation level is less than 90% during sleep with and without the device. Resulting value is in minutes
    Questionnaire: user experience (subjective) after a night with and without the device. Verbal description without scaling satisfaction.

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    October 30, 2016
    Sponsor
    GE Sleeping
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02952118
    Brief Title
    Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
    Official Title
    Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GE Sleeping

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour). Patients with no OSA over the last year will sign an informed consent after receiving explanations from authorized physician (Professor Asher Tal). The patient will than undergo a sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical, Israel) ,an approved device in Israel, USA and many other European countries,, approved for use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more than 15 events per hour of sleep. The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home. Recordings over the nights with or without the "Forrest" epic device will be carried out at the patient's home, after verification that each patient sleeps alone in his/her room. The recording and data processing of snoring will be performed through the application "SNORLAB" on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out during two nights (with and without the Forrest Device) with most patients. During the examination, respiratory index will be tested such as: obstructive respiratory events during sleep, oxygen saturation in blood at rest (measured non-invasively) during sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of oxygen saturation in blood.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Snoring

    7. Study Design

    Primary Purpose
    Prevention
    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
    one night with the device and one night without the device.
    Arm Type
    Experimental
    Arm Description
    The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.
    Intervention Type
    Device
    Intervention Name(s)
    Forrest Snoring device
    Primary Outcome Measure Information:
    Title
    Difference between the two following parameters: (1) Total time of snoring during sleep with the device ("Forest") (2) Total time of snoring during sleep without the device. Resulting value is in minutes.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB
    Time Frame
    1 year
    Title
    Number of obstructive events during sleep. Resulting value is an absolute number.
    Time Frame
    1 year
    Title
    Difference between the two following parameters: (1) Average oxygen saturation level with the device ("Forest") (2) Average oxygen saturation level without the device. Resulting value is in percents (%).
    Time Frame
    1 year
    Title
    Total time during which the oxygen saturation level is less than 90% during sleep with and without the device. Resulting value is in minutes
    Time Frame
    1 year
    Title
    Questionnaire: user experience (subjective) after a night with and without the device. Verbal description without scaling satisfaction.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The patient age range : 20-70 years old. The patient / legal guardian able and willing to sign conscious written agreement. The patient / legal guardian able and willing to comply with the study protocol. The patient is suffering from snoring. The patient underwent a sleep study over the last year. Exclusion Criteria: The patient suffers from sleep apnea that requires CPAP treatment: more than 15 AHI per hour in a sleep study or due to significant background diseases. Patient less than 20 years old.

    12. IPD Sharing Statement

    Learn more about this trial

    Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study

    We'll reach out to this number within 24 hrs