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Upper Airway Training for Treatment of Snoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264963
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
UMN Medical Devices Center
Fairview Sleep Center
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Snoring Other: Smart phone game play Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Upper Airway Training for Treatment of Snoring Using Smartphone Application
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Other: Control
Recording of sleep environment 2 nights per week for 12 weeks
Experimental: Intervention Other: Smart phone game play
Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Snoring Intensity [ Time Frame: 12 weeks ]
    Snoring sounds >60 db

  2. Snoring Rate [ Time Frame: 12 weeks ]
    Snoring sounds/hour of sleep


Secondary Outcome Measures :
  1. Sleep Quality [ Time Frame: 12 weeks ]
    Self reported sleep quality on likert scale (0 to 5)

  2. Bed Partner Sleep Quality [ Time Frame: 12 weeks ]
    Bed partner reported sleep quality on likert scale (0 to 5)

  3. Sleepiness [ Time Frame: 12 weeks ]
    Epworth sleepiness score


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03264963    
Other Study ID Numbers: 1606S88671
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Upper airway exercises
Smart phone application
Additional relevant MeSH terms:
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Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory