Home-based Under Mattress Monitor for OSA

Isabel Moreno Hay

Status: Enrolling

Conditions: Obstructive Sleep Apnea (OSAS); Obstructive Sleep Apnea (SAOS)

Treatments: Device: Mandibular Advancement Device (MAD); Device: Under-mattress monitor; Device: level 3 Home Sleep Apnea Test

Study type: Interventional

Funder types: Other

Identifiers

NCT07186725

97445

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Panthera DSAD mandibular advancement device users

Experimental group

Description:

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.

Treatment:

Device: level 3 Home Sleep Apnea Test

Device: Under-mattress monitor

Device: Mandibular Advancement Device (MAD)