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โ† Trials
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Home-based Under Mattress Monitor for OSA

RecruitingNAAges 18 Years - 80 YearsAllIsabel Moreno Hay
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines. * Willingness to commute to the OFP clinic every 2 weeks during MAD titration period. * Consent to partake in the study. Exclusion Criteria: * Diagnosis of central or mixed sleep apnea. * Neurocognitive disease. * Concomitant therapy with PAP therapy. * Allergic to the appliance material (Polyamide 12). * Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable. * Inadequate English language comprehension. * Lack of coordination or dexterity to insert/remove the MAD intraorally. * Inability to tolerate digital dental impressions. * Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).
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What it tests

  • Under-mattress monitor
  • level 3 Home Sleep Apnea Test
  • Mandibular Advancement Device (MAD)
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Where

1 site
University of Kentucky
Lexington, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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