Mandibular Advancement Device and Changes in Nocturia (MAD)

Improvement in Nocturia With MAD and Changes in Polysomnographic Value

The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; OSA; Nocturia
• Intervention / Treatment: Device: Somnodent Classic

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernanda Yanez Regonesi, DDS, MS; Phone Number: 8593235500; Email: fya232@uky.edu
• Study Contact Backup: Name: Isabel Moreno Hay, DDS, PhD; Phone Number: 8593235500; Email: imo226@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Fernanda Yanez Regonesi, DDS, MS; Phone Number: 859-323-5500; Email: fya232@uky.edu
      • Contact: Isabel Moreno Hay, DDS. PhD; Phone Number: 8593235500; Email: imo226@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Exaggerated gag reflex.
• Lack of coordination or dexterity.
• Inadequate English comprehension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MAD therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 voidings per night is achieved participants will be considers reponders in terms of nocturia and second sleep study will be performed.	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate if response to therapy in terms of nocturia is associated with improvement in AHI	Once participants report less than 2 voiding per night on average (2 week period), second sleep study will be performed and 50% improvement in apnea hypopnea index will be considered treatment success.	15 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	15 weeks

Collaborators and Investigators

• Sponsor: Fernanda Yanez Regonesi
• Collaborators: American Academy of Dental Sleep Medicine
• Investigators: Principal Investigator: Fernanda Yanez Regonesi, DDS, MS, University of Kentucy

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; nocturia; oral appliance; mandibular advancement device
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nocturia
• Other Study ID Numbers: DENT-22-MAD; 177 - DR - 22 (Other Identifier: American Academy of Dental Sleep Mecicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes