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N/A N=58 Treatment

In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study

Snoring

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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