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Mandibular Advancement Device and Changes in Nocturia (MAD)

Primary Purpose

Obstructive Sleep Apnea, Nocturia, OSA

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Somnodent Classic
Sponsored by
Fernanda Yanez Regonesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MAD therapy

Arm Description

MAD Therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2022
Last Updated
August 17, 2023
Sponsor
Fernanda Yanez Regonesi
Collaborators
American Academy of Dental Sleep Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05562388
Brief Title
Mandibular Advancement Device and Changes in Nocturia
Acronym
MAD
Official Title
Improvement in Nocturia With MAD and Changes in Polysomnographic Value
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fernanda Yanez Regonesi
Collaborators
American Academy of Dental Sleep Medicine

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Nocturia, OSA
Keywords
obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAD therapy
Arm Type
Experimental
Arm Description
MAD Therapy
Intervention Type
Device
Intervention Name(s)
Somnodent Classic
Intervention Description
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.
Primary Outcome Measure Information:
Title
To test MAD if associated in changes in nocturia
Description
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.
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Investigate if response to therapy in terms of nocturia is associated with improvement in AHI
Description
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.
Time Frame
15 weeks
Other Pre-specified Outcome Measures:
Title
Changes in quality of life
Description
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.
Time Frame
15 weeks
Title
Change in fatigue
Description
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.
Time Frame
15 weeks
Title
Changes in insomnia
Description
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.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Yanez Regonesi, DDS, MS
Phone
8593235500
Email
fya232@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Moreno Hay, DDS, PhD
Phone
8593235500
Email
imo226@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Yanez Regonesi, DDS, MS
Organizational Affiliation
University Of Kentucy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Yanez Regonesi, DDS, MS
Phone
859-323-5500
Email
fya232@uky.edu
First Name & Middle Initial & Last Name & Degree
Isabel Moreno Hay, DDS. PhD
Phone
8593235500
Email
imo226@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Mandibular Advancement Device and Changes in Nocturia

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