RECRUITING

Mandibular Advancement Device and Changes in Nocturia

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Conditions

Obstructive Sleep ApneaNocturiaOSAoral appliancemandibular advancement device

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Improvement in Nocturia With MAD and Changes in Polysomnographic Value

Quick Facts

Study Start:2023-12-11
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05562388

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaker
  2. * \>18 y/o
  3. * Obstructive sleep apnea diagnosis with AHI≥5
  4. * ≥ 2 voiding/night at baseline
  5. * Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
  6. * Consent to participate in the study.
  1. * Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
  2. * Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia)
  3. * Pregnancy
  4. * Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
  5. * Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
  6. * 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.
  7. * Exaggerated gag reflex.
  8. * Lack of coordination or dexterity.
  9. * Inadequate English comprehension.

Contacts and Locations

Study Contact

Fernanda Yanez Regonesi, DDS, MS
CONTACT
8593235500
fya232@uky.edu
Isabel Moreno Hay, DDS, PhD
CONTACT
8593235500
imo226@uky.edu

Principal Investigator

Fernanda Yanez Regonesi, DDS, MS
PRINCIPAL_INVESTIGATOR
University Of Kentucy

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Fernanda Yanez Regonesi

  • Fernanda Yanez Regonesi, DDS, MS, PRINCIPAL_INVESTIGATOR, University Of Kentucy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • obstructive sleep apnea
  • oral appliance
  • nocturia
  • mandibular advancement device

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Nocturia
  • OSA