Recruiting

Mandibular Device

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05719779

Conditions

Oral Cancer

Pharynx Cancer

Sleep Apnea

Snoring

Oral Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ronco-Onco and MAD

Study Details

Brief summary:

Evaluation of the Tolerance and Benefits of Mandibular Advanced Device (MAD) for Snoring and Sleep Apnea in Patients with Oropharyngeal Cancer (OPC): Mixed Design Study.

Conditions

Oral Cancer

Pharynx Cancer

Sleep Apnea

Snoring

Oral Squamous Cell Carcinoma

Study ID

NCT05719779

Start date

Feb 3, 2023

Status verified date

Aug, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • oropharyngeal cancer diagnosis
  • 18 years of age and over
  • female or male; ratio of 1/4 toward men
  • had received RTH in the Department of Radiation Oncology,
  • reporting snoring and/or respiratory cessation complaints during sleep,

Exclusion Criteria:

  • pregnant or breastfeeding woman;
  • edentation preventing retention of the oral appliance;
  • taking opioid or anxiolitic type medications;
  • history of major depression,
  • uncontrolled hypertension,
  • history of stroke;
  • under treatment with CPAP for sleep apnea;
  • regular and intense orofacial pain;
  • under pharmacological treatment for insomnia;
  • excessive alcohol or drug use (e.g., cannabis, opioid).

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: MAD-active

MAD = mandibular advancement appliance, in 60-70% forward position from maximum possible jaw advancement for a given participant

sham comparator: Neutral MAD- control

Mandibular advancement appliance in neurtral-control position, 10-20% of advancement - a non functional position to open upper airway

Interventions

Ronco-Onco and MAD

Comparison of active over a neutral mandibular advacement oral appliance to assess tolerance and efficacy in oropharyngeal cancer individuals in managing snoring and sleep apnea following radiotherapy of oropharynx.

Primary outcome measure

  • Index apnea-hypopnea [ Time Frame: From sleep onset to wake time (6-8 hrs) in morning of night 1 for baseline vs difference of 2 or 3 according to ramdom allocation ]
  • Snoring [ Time Frame: From sleep onset to wake time (6-8 hrs) in morning of night 1 for baseline vs difference of 2 or 3 according to ramdom allocation ]

Central Contacts and Locations

Central contacts

Gilles Lavigne, DMD, PhD

514-343-2310gilles.lavigne@umontreal.ca

Matthieu Schmittbuhl, DDS, PhD

514 890-8000matthieu.schmittbuhl@umontreal.ca

Locations

CHUM

Recruiting

Montréal, Quebec, Canada, H3X 3E4

Contacts

Karine Peaupert

514-890-8000

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • oropharyngeal cancer
  • snoring
  • sleep apnea
  • oral appliance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-08-15.