SnoringNCT03264963
Upper Airway Training for Treatment of Snoring
A study testing Smart phone game play in people with Snoring, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Snoring
- What is being tested?
- Smart phone game play
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 18 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
About this study
Official title: Upper Airway Training for Treatment of Snoring Using Smartphone Application
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.
- Conditions
- Snoring
- Being tested
- Smart phone game play, Control
- Keywords
- Upper airway exercises, Smart phone application
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart phone game playOther
Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks
ControlOther
Recording of sleep environment 2 nights per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| Intervention | Experimental | Not described Receives: Other: Smart phone game play |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snoring Intensity
Snoring sounds >60 db
Measured: 12 weeks
Snoring Rate
Snoring sounds/hour of sleep
Measured: 12 weeks
Secondary outcomes (3)
Sleep Quality
Self reported sleep quality on likert scale (0 to 5)
Measured: 12 weeks
Bed Partner Sleep Quality
Bed partner reported sleep quality on likert scale (0 to 5)
Measured: 12 weeks
Sleepiness
Epworth sleepiness score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start15 Dec 2016
- Primary completion15 Apr 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- UMN Medical Devices Center, Fairview Sleep Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264963
- Sponsor's protocol ID
- 1606S88671
- Status last verified
- Nov 2017
- First submitted
- 23 Aug 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30032464
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Training for Treatment of Snoring Using Smartphone Application
- ClinicalTrials.gov ID
- NCT03264963
- Acronym / sponsor ID
- 1606S88671
- Conditions
- Snoring
- Keywords
- Upper airway exercises, Smart phone application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- UMN Medical Devices Center, Fairview Sleep Center
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control |
| Intervention | Experimental | Other: Smart phone game play |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart phone game playVoice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks | Other | Intervention |
| ControlRecording of sleep environment 2 nights per week for 12 weeks | Other | Control |
Primary outcome
Snoring Intensity
Time frame: 12 weeks
Snoring sounds >60 db
Snoring Rate
Time frame: 12 weeks
Snoring sounds/hour of sleep
3 secondary outcomes
Sleep Quality
Time frame: 12 weeks
Bed Partner Sleep Quality
Time frame: 12 weeks
Sleepiness
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Derived from this study: PubMed 30032464Goswami 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.
- Individual participant dataSharing planned: Undecided
Related trials for Snoring
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Smart phone game play in people with Snoring, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snoring Intensity (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.