Status:
COMPLETED
In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Lead Sponsor:
Philips Respironics
Conditions:
Snoring
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 a...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03333876
Start Date
October 9 2017
End Date
December 3 2017
Last Update
February 15 2019
Active Locations (1)
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1
Philips Respironics
Murrysville, Pennsylvania, United States, 15668