Status:
COMPLETED
Upper Airway Training for Treatment of Snoring
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
UMN Medical Devices Center
Fairview Sleep Center
Conditions:
Snoring
Eligibility:
All Genders
20-65 years
Phase:
NA
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03264963
Start Date
December 15 2016
End Date
May 18 2017
Last Update
November 8 2017
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