Image

Home-based Under Mattress Monitor for OSA

Home-based Under Mattress Monitor for OSA

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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

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).

Study details
    Obstructive Sleep Apnea (OSAS)
    Obstructive Sleep Apnea (SAOS)

NCT07186725

Isabel Moreno Hay

26 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.