Mandibular Advancement Device and Changes in Nocturia

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; Nocturia; OSA
• Interventions: Device: Somnodent Classic

• Registration Number: NCT05562388
• Lead Sponsor: Fernanda Yanez Regonesi

Brief Summary

The main purpose of this study is to test is mandibular advacenment 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 Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2023-12-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAD therapy	Somnodent Classic	MAD Therapy

Primary Outcome Measures

Name	Time	Method
To test MAD if associated in changes in nocturia	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 voidings per night is achieved participants will be considers reponders in terms of nocturia and second sleep study will be performed.

Secondary Outcome Measures

Name	Time	Method
Investigate if response to therapy in terms of nocturia is associated with improvement in AHI	15 weeks	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States