Upper Airway Training for Treatment of Snoring
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ClinicalTrials.gov Identifier: NCT03264963 |
Recruitment Status :
Completed
First Posted : August 29, 2017
Last Update Posted : November 8, 2017
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Sponsor:
University of Minnesota
Collaborators:
UMN Medical Devices Center
Fairview Sleep Center
Information provided by (Responsible Party):
University of Minnesota
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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 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 |
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 |
Primary Outcome Measures :
- Snoring Intensity [ Time Frame: 12 weeks ]Snoring sounds >60 db
- Snoring Rate [ Time Frame: 12 weeks ]Snoring sounds/hour of sleep
Secondary Outcome Measures :
- Sleep Quality [ Time Frame: 12 weeks ]Self reported sleep quality on likert scale (0 to 5)
- Bed Partner Sleep Quality [ Time Frame: 12 weeks ]Bed partner reported sleep quality on likert scale (0 to 5)
- Sleepiness [ Time Frame: 12 weeks ]Epworth sleepiness score
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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:
- Fluent in English.
- Age is between 20 and 65.
- BMI less than 32
- Less than 5% variance in weight since sleep study.
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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.
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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:
Snoring Respiratory Sounds Signs and Symptoms, Respiratory |