Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer.

NCT05719779 | Recruiting DMC

• 1 other identifier: 22.204
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

oropharyngeal cancer; snoring; sleep apnea; oral appliance

Outcome Measures

Primary Outcomes (2)

• Index apnea-hypopnea

  respiratory cessation index (number of event per hour of sleep, 1 to max of 100, rare value)

  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

  Total snoring time (minute per sleep duration of a given participant, average as mean or median) and event frequency (number of event per hour of sleep) - values expected from 0 to 100 for each outcome

  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

Secondary Outcomes (1)

• Sleep quality

  Done in morning from 6-8 sleep period, assessed in morning of each of 3 nights

Study Arms (2)

MAD-active

ACTIVE COMPARATOR

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

Device: Ronco-Onco and MAD

Neutral MAD- control

SHAM COMPARATOR

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

Device: Ronco-Onco and MAD

Interventions

Ronco-Onco and MAD DEVICE

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.

MAD-active; Neutral MAD- control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• oropharyngeal cancer diagnosis
• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, H3X 3E4, Canada

RECRUITING

Related Publications (1)

• Dal Fabbro C, Harris P, Dufresne E, Herrero Babiloni A, Mayer P, Bahig H, Filion E, Nguyen F, Ghannoum J, Schmittbuhl M, Lavigne G. Orofacial Pain and Snoring/Obstructive Sleep Apnea in Individuals with Head and Neck Cancer: A Critical Review. J Oral Facial Pain Headache. 2022 Spring;36(2):85-102. doi: 10.11607/ofph.3176.

  PMID: 35943322 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Pharyngeal Neoplasms; Sleep Apnea Syndromes; Snoring; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Gilles Lavigne, DMD, PhD

CONTACT

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

Matthieu Schmittbuhl, DDS, PhD

CONTACT

514 890-8000; matthieu.schmittbuhl@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant no informed on the oral appliance position, ie.e, degree of advancement Outcome assessor also not informaed of applaince position: control or active-forward.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active oral appliance in 60-70% advanced position of maximum jaw possible advancement for a given participant over the control position= neutral position one in 10-20% (no fucntional opening of upper airway at that position)

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 9, 2023
• Study Start: February 3, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after study completion
• Access Criteria: To be updated according to our institution policies - these are regularly revised

Locations

CA (1)