NCT07186725|RecruitingFDA Device
Home-based Under Mattress Monitor for OSA
Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
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Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
Sponsor study identifier
interventional
70
1 country
1
Study Start
January 7, 2026
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2025
Actual (reported)September 22, 2025
Actual (reported)January 7, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in apnea-hypopnea index (AHI).
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)
Baseline and post-intervention (approximately 12 weeks)
Change in minimum oxygen desaturation level
The minimum O2 level percentage during treatment
Baseline and post-intervention (approximately 12 weeks)
Change in Epworth Sleepiness Scale
Baseline and post-intervention (approximately 12 weeks)
Change in Quality of Life Scale
Baseline and post-intervention (approximately 12 weeks)
Change in Fatigue Assessment Scale
Baseline and post-intervention (approximately 12 weeks)
Change in Pittsburgh Sleep Quality Index (PSQI)
Baseline and post-intervention (approximately 12 weeks)
Change in Snore Outcomes Survey (SOS)
Baseline and post-intervention (approximately 12 weeks)
Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.
the under-mattress monitor will be used in conjunction with the Alice NightOne at the beginning and end of the study, in addition, the under-mattress monitor will be used daily during sleep with the intraoral device in situ
Home sleep apnea test with Alice NightOne will be used for one day during sleep at the beginning and end of the study in conjunction with the Sleeptracker AI and the intraoral device.
University of Kentucky
Lexington, Kentucky, 40506, United States
Isabel Moreno Hay, DDS, PhD
University of Kentucky
First Submitted
September 15, 2025
First Posted
September 22, 2025
Study Start
January 7, 2026
Actual (reported)Primary Completion
March 2027
EstimatedCAD-CAM, US Food and Drug Administration (FDA)-approved MAD, duo-bloc, customized, titratable sleep appliance. Participants will return every 2 weeks to the Orofacial Pain (OFP) clinic to progressively titrate the MAD advancement as needed until the under-mattress monitor scores an AHI \< 5
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 3, 2026
Record last verified: 2026-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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