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Upper Airway Training for Treatment of Snoring

Primary Purpose

Snoring

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart phone game play
Control
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Upper airway exercises, Smart phone application

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Fluent in English.
  2. Age is between 20 and 65.
  3. BMI less than 32
  4. Less than 5% variance in weight since sleep study.

  5. Snoring without health risk related to sleep apnea and not currently receiving treatment.

    1. Mild OSA or negative HSAT or PSG within past year with AHI 0-14
    2. Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.
  6. Owns an iPhone 4 or newer and is comfortable downloading and using apps.
  7. Complaint of habitual snoring 3 or more nights per week
  8. Rated by polysomnograph technologist as moderate or loud snoring.

Exclusion Criteria:

  1. Non-fluent in English.
  2. Persistent rhinitis diagnosis or nasal obstruction.
  3. BMI > 32
  4. Greater than 5% variance in weight since sleep study.
  5. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS)
  6. Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report.
  7. Spouse/partner is also a habitual snorer.
  8. Lacking ability to consent for themselves.
  9. Heavy drinker (self reported average more than 2 drinks per day).
  10. Regular narcotics (greater than 3 times/week)
  11. Epworth sleepiness scale score > 11 or one near miss accident in the past 6 months.
  12. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Snoring Intensity
    Snoring sounds >60 db
    Snoring Rate
    Snoring sounds/hour of sleep

    Secondary Outcome Measures

    Sleep Quality
    Self reported sleep quality on likert scale (0 to 5)
    Bed Partner Sleep Quality
    Bed partner reported sleep quality on likert scale (0 to 5)
    Sleepiness
    Epworth sleepiness score

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    November 6, 2017
    Sponsor
    University of Minnesota
    Collaborators
    UMN Medical Devices Center, Fairview Sleep Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03264963
    Brief Title
    Upper Airway Training for Treatment of Snoring
    Official Title
    Upper Airway Training for Treatment of Snoring Using Smartphone Application
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 15, 2016 (Actual)
    Primary Completion Date
    April 15, 2017 (Actual)
    Study Completion Date
    May 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota
    Collaborators
    UMN Medical Devices Center, Fairview Sleep Center

    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
    The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Snoring
    Keywords
    Upper airway exercises, Smart phone application

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Smart phone game play
    Intervention Description
    Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Recording of sleep environment 2 nights per week for 12 weeks
    Primary Outcome Measure Information:
    Title
    Snoring Intensity
    Description
    Snoring sounds >60 db
    Time Frame
    12 weeks
    Title
    Snoring Rate
    Description
    Snoring sounds/hour of sleep
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Sleep Quality
    Description
    Self reported sleep quality on likert scale (0 to 5)
    Time Frame
    12 weeks
    Title
    Bed Partner Sleep Quality
    Description
    Bed partner reported sleep quality on likert scale (0 to 5)
    Time Frame
    12 weeks
    Title
    Sleepiness
    Description
    Epworth sleepiness score
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fluent in English. Age is between 20 and 65. BMI less than 32 Less than 5% variance in weight since sleep study. Snoring without health risk related to sleep apnea and not currently receiving treatment. Mild OSA or negative HSAT or PSG within past year with AHI 0-14 Has refused oral appliances, CPAP, weight loss, surgery or positional therapy. Owns an iPhone 4 or newer and is comfortable downloading and using apps. Complaint of habitual snoring 3 or more nights per week Rated by polysomnograph technologist as moderate or loud snoring. Exclusion Criteria: Non-fluent in English. Persistent rhinitis diagnosis or nasal obstruction. BMI > 32 Greater than 5% variance in weight since sleep study. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS) Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report. Spouse/partner is also a habitual snorer. Lacking ability to consent for themselves. Heavy drinker (self reported average more than 2 drinks per day). Regular narcotics (greater than 3 times/week) Epworth sleepiness scale score > 11 or one near miss accident in the past 6 months. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30032464
    Citation
    Goswami U, Black A, Krohn B, Meyers W, Iber C. Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial. Sleep Breath. 2019 Mar;23(1):243-250. doi: 10.1007/s11325-018-1690-y. Epub 2018 Jul 21.
    Results Reference
    derived

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    Upper Airway Training for Treatment of Snoring

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