Obstructive Sleep Apnea (OSAS)NCT07186725
Home-based Under Mattress Monitor for OSA
A study testing Under-mattress monitor, level 3 Home Sleep Apnea Test and Mandibular Advancement Device (MAD) in people with Obstructive Sleep Apnea (OSAS) and Obstructive Sleep Apnea (SAOS), run by Isabel Moreno Hay at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSAS), Obstructive Sleep Apnea (SAOS)
- What is being tested?
- Under-mattress monitor, level 3 Home Sleep Apnea Test and Mandibular Advancement Device (MAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Sumia Alyousef, BDS, 8593235500, Sumia.Alyousef@uky.edu
About this study
Official title: Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
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.
- Being tested
- Under-mattress monitor, level 3 Home Sleep Apnea Test, Mandibular Advancement Device (MAD)
- Keywords
- Mandibular Advancement, Sleep Apnea, Oral Appliance, Home-based, Obstructive Sleep Apnea, Home-based device
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Under-mattress monitorDevice
Also called Sleeptracker-AI
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
level 3 Home Sleep Apnea TestDevice
Also called Alice NightOne
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.
Mandibular Advancement Device (MAD)Device
Also called D-SADTM Panthera Dental
CAD-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
| Study group | Role | What they receive |
|---|---|---|
| Panthera DSAD mandibular advancement device users | Experimental | 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. Receives: Device: Under-mattress monitor; Device: level 3 Home Sleep Apnea Test; Device: Mandibular Advancement Device (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and post-intervention (approximately 12 weeks)
Change in minimum oxygen desaturation level
The minimum O2 level percentage during treatment
Measured: Baseline and post-intervention (approximately 12 weeks)
Secondary outcomes (6)
Change in Epworth Sleepiness Scale
This scale measures daytime sleepiness. Scores range from 0-24. Higher scores indicate more severe daytime sleepiness.
Measured: Baseline and post-intervention (approximately 12 weeks)
Change in Quality of Life Scale
Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
Measured: Baseline and post-intervention (approximately 12 weeks)
Change in Fatigue Assessment Scale
The scale consists of 10 questions about the characteristics of fatigue in the current daily routine. The scale scores range from 10-50, with higher score indicating higher level of fatigue.
Measured: Baseline and post-intervention (approximately 12 weeks)
Change in Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire that includes seven areas of sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). A high total scale score indicates poor sleep quality.
Measured: Baseline and post-intervention (approximately 12 weeks)
Change in Snore Outcomes Survey (SOS)
SOS consists of eight items related to the frequency, duration, severity, and consequences associated with sleep-disordered breathing and specifically snoring. Respondents use several Likert-type scales to answer questions regarding their snoring, with lower scores indicating more acute problems with SDB. Scores are normalized on a scale from 0 to 100.
Measured: Baseline and post-intervention (approximately 12 weeks)
Short Assessment of Patient Satisfaction
Patient satisfaction with MAD will be measured by a 7-item questionnaire scored on a Likert type scale. Scores range from 7 to 35. Higher scores equate to greater satisfaction.
Measured: Post Intervention, approximately week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start7 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabel Moreno Hay
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Dental Sleep Medicine
- Responsible party
- Sponsor-investigator, Isabel Moreno Hay, University of Kentucky
- Investigators
- Isabel Moreno Hay, DDS, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186725
- Sponsor's protocol ID
- 97445
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07186725
- Acronym / sponsor ID
- 97445
- Keywords
- Mandibular Advancement, Sleep Apnea, Oral Appliance, Home-based, Obstructive Sleep Apnea, Home-based device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Isabel Moreno HayUniversity, hospital or other
- Collaborators
- American Academy of Dental Sleep Medicine
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panthera DSAD mandibular advancement device users | Experimental | Device: Under-mattress monitor, Device: level 3 Home Sleep Apnea Test, Device: Mandibular Advancement Device (MAD)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Under-mattress monitorAlso: Sleeptracker-AIthe 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 | Device | Panthera DSAD mandibular advancement device users |
| level 3 Home Sleep Apnea TestAlso: Alice NightOneHome 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. | Device | Panthera DSAD mandibular advancement device users |
| Mandibular Advancement Device (MAD)Also: D-SADTM Panthera DentalCAD-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 | Device | Panthera DSAD mandibular advancement device users |
Primary outcome
Change in apnea-hypopnea index (AHI).
Time frame: Baseline and post-intervention (approximately 12 weeks)
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)
Change in minimum oxygen desaturation level
Time frame: Baseline and post-intervention (approximately 12 weeks)
The minimum O2 level percentage during treatment
6 secondary outcomes
Change in Epworth Sleepiness Scale
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Quality of Life Scale
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Fatigue Assessment Scale
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and post-intervention (approximately 12 weeks)
Change in Snore Outcomes Survey (SOS)
Time frame: Baseline and post-intervention (approximately 12 weeks)
Short Assessment of Patient Satisfaction
Time frame: Post Intervention, approximately week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabel Moreno Hay, DDS, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Under-mattress monitor, level 3 Home Sleep Apnea Test and Mandibular Advancement Device (MAD) in people with Obstructive Sleep Apnea (OSAS) and Obstructive Sleep Apnea (SAOS), run by Isabel Moreno Hay at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumia Alyousef, BDS ((859) 323-3440, Sumia.Alyousef@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI). (time frame: Baseline and post-intervention (approximately 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.