Obstructive Sleep ApneaMADNCT05562388
Mandibular Advancement Device and Changes in Nocturia
A study testing Somnodent Classic in people with Obstructive Sleep Apnea and Nocturia, run by Isabel Moreno Hay at 1 site in United States.
Trial summary
The main purpose of this study is to test is mandibular advancement device (MAD) use is associated with reductions in nocturia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Nocturia, OSA
- What is being tested?
- Somnodent Classic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English speaker
- >18 y/o
- Obstructive sleep apnea diagnosis with AHI≥5
- ≥ 2 voiding/night at baseline
- Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
- Consent to participate in the study.
Who cannot join
- Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
- Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia)
- Pregnancy
- Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
- Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
- Upon clinical examination: periodontal disease (>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility >1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
Show all 9Show fewer
- Exaggerated gag reflex.
- Lack of coordination or dexterity.
- Inadequate English comprehension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement in Nocturia With MAD and Changes in Polysomnographic Value
The main purpose of this study is to test is mandibular advancement device (MAD) use is associated with reductions in nocturia.
Read the detailed description
After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.
- Conditions
- Obstructive Sleep Apnea, Nocturia, OSA
- Being tested
- Somnodent Classic
- Keywords
- obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device
- Medical subject headings
- Sleep Apnea, Obstructive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somnodent ClassicDevice
The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI.
| Study group | Role | What they receive |
|---|---|---|
| MAD therapy | Experimental | MAD Therapy Receives: Device: Somnodent Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Test MAD if Associated in Changes in Nocturia
Assessment of efficacy of device in terms of nocturia: Patients will complete daily questionnaires to evaluate voiding at night. Average of 2 preceding weeks of the follow up will be used to determine treatment success in terms of nocturia. Once less than 2 voiding's per night is achieved participants will be considers responders in terms of nocturia and second sleep study will be performed.
Measured: 15 weeks
Secondary outcomes (1)
Association Between Change in Nocturia Episodes and Change in Apnea-Hypopnea Index (API)
Pearson Correlation Coefficient between the change in Baseline to Week 15 in average nightly nocturia episodes and the change from Baseline to Week 15 in Apnea-Hypopnea Index (API) following mandibular advancement device therapy.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start11 Dec 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- Fernanda Yanez Regonesi, DDS, MS, Principal investigator, University Of Kentucy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562388
- Sponsor's protocol ID
- DENT-22-MAD
- Other IDs
- 177 - DR - 22
- Acronym
- MAD
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2022
- Last updated
- 27 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Nocturia With MAD and Changes in Polysomnographic Value
- ClinicalTrials.gov ID
- NCT05562388
- Acronym / sponsor ID
- MAD / DENT-22-MAD
- Conditions
- Obstructive Sleep Apnea, Nocturia, OSA
- Keywords
- obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Isabel Moreno HayUniversity, hospital or other
- Collaborators
- American Academy of Dental Sleep Medicine
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 27 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to test is mandibular advancement device (MAD) use is associated with reductions in nocturia.
Detailed description
After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.
| Arm | Type | Receives |
|---|---|---|
| MAD therapy | Experimental | Device: Somnodent ClassicMAD Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English speaker
- >18 y/o
- Obstructive sleep apnea diagnosis with AHI≥5
- ≥ 2 voiding/night at baseline
- Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
Key exclusion criteria (9 listed)
- Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
- Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia)
- Pregnancy
- Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
- Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
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 |
|---|---|---|
| Somnodent ClassicThe efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI. | Device | MAD therapy |
Primary outcome
To Test MAD if Associated in Changes in Nocturia
Time frame: 15 weeks
Assessment of efficacy of device in terms of nocturia: Patients will complete daily questionnaires to evaluate voiding at night. Average of 2 preceding weeks of the follow up will be used to determine treatment success in terms of nocturia. Once less than 2 voiding's per night is achieved participants will be considers responders in terms of nocturia and second sleep study will be performed.
1 secondary outcome
Association Between Change in Nocturia Episodes and Change in Apnea-Hypopnea Index (API)
Time frame: 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Fernanda Yanez Regonesi, DDS, MS principal investigator
University Of Kentucy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnodent Classic in people with Obstructive Sleep Apnea and Nocturia, 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 6 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: finished, as of the sponsor's last update on 27 Aug 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?
Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Test MAD if Associated in Changes in Nocturia (time frame: 15 weeks). 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 27 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.