Trial Outcomes & Findings for Mandibular Advancement Device and Changes in Nocturia (NCT NCT05562388)

Last Updated: 2026-08-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

15 weeks

Results posted on

2026-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	MAD Therapy MAD Therapy 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.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mandibular Advancement Device and Changes in Nocturia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAD Therapy n=11 Participants MAD Therapy 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.
Age, Continuous	50.36 years STANDARD_DEVIATION 12.86 • n=31 Participants
Sex: Female, Male Female	7 Participants n=31 Participants
Sex: Female, Male Male	4 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	0 Participants n=31 Participants
Race (NIH/OMB) White	11 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Region of Enrollment United States	11 participants n=31 Participants

PRIMARY outcome

Timeframe: 15 weeks

Outcome measures

Outcome measures
Measure	MAD Therapy n=11 Participants MAD Therapy 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 Baseline	2.33 Episodes per night Standard Deviation 0.6
To Test MAD if Associated in Changes in Nocturia Follow-Up	1.13 Episodes per night Standard Deviation 0.36

SECONDARY outcome

Timeframe: 15 weeks

Population: Pearson correlation coefficient was used to compared the changes in nocturia with changes in Apnea-Hypopnea Index (AHI)

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.

Outcome measures

Outcome measures
Measure	MAD Therapy n=11 Participants MAD Therapy 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.
Association Between Change in Nocturia Episodes and Change in Apnea-Hypopnea Index (API)	0.165 Correlation Coefficient

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 weeks

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 weeks

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 weeks

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.

Outcome measures

Outcome data not reported

Adverse Events

MAD Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Isabel Moreno Hay

University of Kentucky

Phone: 8593235500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place