N/A
N=58
In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Snoring
Bottom Line
View on ClinicalTrials.gov: NCT03333876 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring — 5.0; 3.8; 4.4 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal Dilator (Device); Mandibular Advancement (Device); Positional Therapy (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring |
5.0; 3.8; 4.4 | <.001 sig |
| SECONDARY Users Acceptance of Each Solution |
3.4; 2.7; 3.1; 6.3; 4.4; 5.5 | — |
| SECONDARY Understand User Acceptance of the Bed Partner of Each Solution |
4.4; 4.6; 5.4 | — |
| SECONDARY Overall Satisfaction of the Bed Partner of Each Solution |
5.0; 5.3; 6.6 | — |
| SECONDARY Total Number of Audio Recordings |
113; 168; 328; 308 | — |
Summary
Silent Night is a solution for primary snorers to guide them to the proper anti-snoring solution. It consists of a mobile application, which had an intake questionnaire, guides users to one of three anti-snoring solutions; a nasal dilator called, Mute (Rhinomed, Australia), a mandibular advancement device called myTAP V (Airway Management, Austin, TX) and a Sleep Positional Trainer SPT (SPT) (NightBalance, Netherlands). The Silent Night app also records snoring through the night and provides feedback to the user via a "snore score."
Eligibility Criteria
Inclusion Criteria (Snorer):
- Adults aged 21 to 55
- Able and willing to provide written informed consent
- Able to read and understand English
- History of snoring for more than 6 months (by self-report).
- Sleep with a bed partner for at least 4 nights per week (by self-report).
- Told by bed partner that snoring frequently disturbs his or her sleep (by self-report).
- Have seen a dentist within 12 months (by self-report).
- Willing to not use any anti-snoring aids that are not associated with the study (by self-report).
- Has purchased or used or bed partner has purchased an anti-snoring product in the past (by self-report) [These individuals may be included in the study if recruitment timeline dictates it]
Exclusion Criteria (Snorer):
- Scored higher than a 9 on the Modified Snore Scale Score (MSSS>9)
- Scored higher than a 6 on the OSA 50 screener (OSA50>6)
- The presence of physical or mental limitations that would limit the ability to use the anti-snoring solutions.
- Any unstable medical condition like congestive heart failure, neuromuscular disease, renal failure, or cancer (as determined by self-report and reviewed by the study PI).
- Any severe respiratory condition (like an exacerbation of Chronic Obstructive Pulmonary Disease, bronchitis, sinusitis, respiratory failure or insufficiency or patients requiring oxygen therapy).
- Known history of Obstructive Sleep Apnea (OSA) or Central Sleep Apnea Syndrome (by self-report)
- Only able to sleep in the supine (flat on one's back) position (by self-report).
- Actively suffering from an upper respiratory infection (by self-report).
- Have a planned medical or dental procedure involving the head, neck, face (eyes, ears, nose, teeth, mouth), or lungs during the trial period (by self-report).
- Under active treatment for an active dental problem by a dentist or orthodontist
- Have one or more of the following dental issues (by self-report)
- Removable dentures or bridges.
- Temporary crowns, loose teeth, loose crowns, loose fillings, or broken teeth
- Less than 8 natural, healthy teeth in each dental arch (upper and lower teeth)
- Dental braces
- TemporoMandibular Joint (TMJ) issues
Inclusion Criteria (Bed Partner):
- Adults aged 21 to 70
- Able and willing to provide written informed consent
- Able to read and understand English
- Rates sleep disturbance caused by partner's snoring greater than or equal to 4 on a scale of 1-10
- Rates level of snoring volume greater than or equal to 7 on a scale of 1-10
- Willing to sleep in same room as snorer during the study period (by self -report).
- Willing to not start any new over-the-counter or prescription sleep medication including sedatives and hypnotics during the study period (by self-report).
Exclusion Criteria (Bed Partner):
- Told by bed partner that their snoring frequently disturbs his or her sleep (by self-report).
Data sourced from ClinicalTrials.gov (NCT03333876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.