Home-based Under Mattress Monitor for OSA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIsabel Moreno Hay
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Diagnosis of central or mixed sleep apnea.
Neurocognitive disease.
Concomitant therapy with PAP therapy.
Allergic to the appliance material (Polyamide 12).
Trial design
Treatments tested in this trial
- Under-mattress monitor
- level 3 Home Sleep Apnea Test
- Mandibular Advancement Device (MAD)
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Isabel Moreno Hay
Lead sponsor
University of Kentucky
Sponsor institution
American Academy of Dental Sleep Medicine
Collaborator
Source ClinicalTrials.gov