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

ConditionsOral CancerPharynx CancerSleep ApneaSnoringOral Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

pregnant or breastfeeding woman;

edentation preventing retention of the oral appliance;

taking opioid or anxiolitic type medications;

history of major depression,

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: MAD-activeActive comparator 1 intervention
Group B: Neutral MAD- controlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Index apnea-hypopnea

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

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
2

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

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

Secondary outcomes

1

Sleep quality

Duration (estimated by participant in number of hour) and self perception of quality (0-10 visual analog scale)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Source ClinicalTrials.gov
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