An interventional study of Somnodent Classic in Obstructive Sleep Apnea, Nocturia and OSA, sponsored by Isabel Moreno Hay. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Isabel Moreno Hay · Not applicable, Interventional, and Treatment
Among 751 studies in Sleep Apnea, Obstructive with a site in United States — 126 open to participants now, 159 under way, 9 of them phase 3. Sleep Apnea, Obstructive · United States.
Among the 751 studies in Sleep Apnea, Obstructive with a site in United States, this one is the 505th largest by enrollment of the 592 interventional ones, is one of 42 that started in 2023, is one of 408 with no phase, and was the 594th registered.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 11 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →126 of the 751 studies in Sleep Apnea, Obstructive with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 145 (46%) set no upper age limit and 125 (40%) stop at 75 or younger; 53 take children under 18; 65 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →751 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 42 started in 2023.
Median enrollment 50 across the 592 interventional studies, 81 across the 157 observational. Of the 511 that completed or were terminated, 256 (50%) have results posted.
191 of 751 have an industry lead sponsor. The 10 most frequent:
Isabel Moreno Hay is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Isabel Moreno Hay has 4 studies filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
65 of the studies in Sleep Apnea, Obstructive with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT04814420Tulane UniversityAtrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study | 2026-11 |
| NCT07103941Isabel Moreno HayIOA Preventing Occlusal Changes With MAD Use | 2026-11-28 |
| NCT01857427Ulysses Magalang MDA Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities | 2026-12 |
Among the 751 studies in Sleep Apnea, Obstructive with a site in United States, from their registry updates:
The main purpose of this study is to test is mandibular advancement device (MAD) use is associated with reductions in nocturia.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MAD Therapy
Device: Somnodent Classic
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.
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.
Time frame: 15 weeks
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.
Time frame: 15 weeks
Changes in Quality of Life
Evaluate changes in quality of life after MAD treatment and see how changes correlate with changes in nocturia. The outcomes will be evaluated with health related quality of life questionnaire at baseline and at the last follow up.
Time frame: 15 weeks
Change in Fatigue
Evaluate changes in fatigue symptomatology after MAD treatment and see how changes in correlate with changes in nocturia. The outcomes will be evaluated with fatigue assessment scale at baseline and at the last follow up.
Time frame: 15 weeks
Changes in Insomnia
Evaluate changes insomnia symptomatology after MAD treatment and see how changes correlate with changes in nocturia. The outcomes will be evaluated with insomia severity index questionnaire at baseline and at the last follow up.
Time frame: 15 weeks
| Milestone | MAD Therapy |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| Episodes per night | MAD Therapy |
|---|---|
| Baseline | 2.33 ± 0.6 |
| Follow-Up | 1.13 ± 0.36 |
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.
| Correlation Coefficient | MAD Therapy |
|---|---|
| Association Between Change in Nocturia Episodes and Change in Apnea-Hypopnea Index (API) | 0.165 |
Evaluate changes in quality of life after MAD treatment and see how changes correlate with changes in nocturia. The outcomes will be evaluated with health related quality of life questionnaire at baseline and at the last follow up.
Results for this outcome have not been posted.
Evaluate changes in fatigue symptomatology after MAD treatment and see how changes in correlate with changes in nocturia. The outcomes will be evaluated with fatigue assessment scale at baseline and at the last follow up.
Results for this outcome have not been posted.
Evaluate changes insomnia symptomatology after MAD treatment and see how changes correlate with changes in nocturia. The outcomes will be evaluated with insomia severity index questionnaire at baseline and at the last follow up.
Results for this outcome have not been posted.
Collected over From study enrollment through study completion (approximately 19 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MAD Therapy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | MAD Therapy |
|---|---|
| Mean | 50.36 ± 12.86 |
| Sex: Female, Male(Participants) | MAD Therapy |
|---|---|
| Female | 7 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | MAD Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | MAD Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | MAD Therapy |
|---|---|
| United States | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2023 to primary completion in Jul 2025, 19 months.
Results were first posted in Aug 2026, 1 year after primary completion.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 19 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Isabel Moreno Hay