Mandibular Advancement Device and Changes in Nocturia

Obstructive Sleep Apnea Clinical Trial

— MAD  

Official title:

Improvement in Nocturia With MAD and Changes in Polysomnographic Value

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562388
• Other study ID #: DENT-22-MAD
• Secondary ID: 177 - DR - 22
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: Fernanda Yanez Regonesi, DDS, MS
• Phone: 8593235500
• Email: fya232[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nocturia
• Obstructive Sleep Apnea
• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Fernanda Yanez Regonesi	American Academy of Dental Sleep Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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