MAD: Mandibular Advancement Device and Changes in Nocturia

Sponsor

Fernanda Yanez Regonesi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05562388

Collaborator

American Academy of Dental Sleep Medicine (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Nocturia OSA	Device: Somnodent Classic	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Improvement in Nocturia With MAD and Changes in Polysomnographic Value

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Changes in quality of life [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.
Change in fatigue [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.
Changes in insomnia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.