Trial Title:
Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer.
NCT ID:
NCT05719779
Condition:
Oral Cancer
Pharynx Cancer
Sleep Apnea
Snoring
Oral Squamous Cell Carcinoma
Conditions: Official terms:
Mouth Neoplasms
Oropharyngeal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Pharyngeal Neoplasms
Apnea
Sleep Apnea Syndromes
Snoring
Conditions: Keywords:
oropharyngeal cancer
snoring
sleep apnea
oral appliance
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
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)
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Device
Intervention name:
Ronco-Onco and MAD
Description:
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.
Arm group label:
MAD-active
Arm group label:
Neutral MAD- control
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.
Detailed description:
The department of stomatology of the CHUM (Centre Hospitalier Université de Montreal)
mandate is to ensure oral management of patients with oropharyngeal cancers (OPC),
including papillomavirus (HPV), treated with radiotherapy (RTH), surgery and
chemotherapy. At CHUM clinic, several patients who have had RTH treatments (with or
without surgery or/and chemotherapy) complain of snoring and respiratory arrest during
sleep. HPV-associated OPC, squamous cell carcinoma, has had a net increasing incidence
for more than 20 years in North America (4.6/100,000) and male mortality has increased by
3.1% per year since 2001. In Quebec, the incidence is almost 26 cases per million.
Worldwide, it is ranked to be the 13 most common cancer in male aged 25-39 years; the
male/female ratio is 2.5 (female have more HPV cervix related cancer) - Global oral
health status report: towards universal health coverage for oral health by 2030- (Geneva:
World Health Organization; 2022).
Snoring occurs in nearly 40% of the general population, increases with age and can be one
of the telltale signs of sleep apnea (brief and repetitive breathing stops at risk of
mortality if left untreated). Snoring can be associated with poor sleep quality and
produces a loud disturbing noise for the sleeping partner. Obstructive sleep apnea (OSA)
is reported by 2-4% of the general population and by almost 30% of the elderly mainly
related to obesity and heart disorders. The risk factors associated with these conditions
are lost of airway muscle tone during sleep, retrognathia, deep/narrow palate, obesity
and age. Fatigue and drowsiness are markers of OSA. Following RTH, there may be
oropharyngeal tissue fibrosis that may contribute to snoring and sleep apnea.
Sleep disordered breathing are known in individuals with OPC. Our first results of the
ongoing survey seem to indicate that severe snoring, causing drowsiness or fatigue, would
be present in 47% of patients with OPC. A recently published literature review, from our
team, also found a snoring self-reports prevalence from 33% to 82%. A polygraphic sleep
recording study found that 65% of individuals with head and neck cancer (including OPC)
have snoring, a value that increases to 92% when OSA is concomitant. On the other hand,
OSA seem to be present in over 70% of OPC patients, before and after treatment. However,
causality remains to be demonstrated; these sleep disorders are often pre-existing and
can worsen as a result of RTH.
In adults, snoring is mainly controlled by devices correcting the dorsal position of
sleep as well as with mandibular advanced device (MAD). Regarding apnea, positive
pressure vessels (PPC or CPAP) are the most effective. The MAD is indicated for mild to
moderate OSA or for low CPAP tolerance. To date, following RTH, there are no studies
conducted under strict conditions. Some 'suggestions' in favour of standard treatments,
PPC or MAD, were made. In addition, no studies have estimated the nasal discomfort and
dryness associated with these treatments in the OPC population. Intuitively, nylon MAD,
thin and with little contact on the mucous membranes, could be indicated in the presence
of OPC. To date, only one study, based on 2 cases, suggests the use of MAD in the
presence of OPC. There is therefore a gap of evidences in the literature as to whether
patients treated for OPC presenting snoring and OSA would be able to tolerate and benefit
from MAD.
Objectives: Conduct a pilot study, with a mixed quantitative and qualitative design, to
reduce snoring or sleep apnea using an MAD, and improve the quality of life and sleep.
Hypotheses: Individuals who have received RTH as part of a treatment for OPC and who have
snoring or OSA, can 1) tolerate and 2) benefit from treatment with MAD.
Experimental method and approach.
- Study design: Pilot trial, mixed and sequential design, randomized with active MAD
vs. non-active MAD (control) and single-blind condition analyses for the
participant. The D-SAD nylon MAD is marketed by Panthera Dental (Quebec) and
provided free of charge as part of this project. The study includes a total of 8
visits to CHUM: 5 for clinical appointments and 3 nights of home sleep data
collection. The 3 nights of sleep recordings will be spaced 4-5 weeks apart for
adaptation to MAD. Night 1 will be for basal level, and nights 2 and 3 for
recordings with active MAD or control. This will be done under the supervision of
sleep lab director of CHUM, collaborator for over 25 years and residents. -- -
Population: Adult patients (+18 years, female or male; ratio of 1/4 toward men;
female is a rare phenotype of OSA pre-menopause) who received RTH in the Department
of Radiation Oncology, with snoring-respiratory complaints during sleep, and
follow-up in Stomatology at CHUM for OPC. Exclusions: Pregnant or breastfeeding
woman; edentation preventing retention of the MAD; taking opioid-type medications;
history of major depression, uncontrolled hypertension, 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).
Recruitment: With the help of CHUM radiation oncology and dental staff (dentist and
dental hygienist, resident). An informed consent will be completed.
- Sample size: It is expected that 24 participants (risk of 2-4 dropouts based on our
experience) will be recuited. A 30% reduction in snoring and apnea/h is expected;
this based on publications and an estimate of sample size. Indeed, a statistician,
estimated that for a 30% decrease in snoring/night time (base at 8.9%/night, SD
3.4%) 15 participants are required for an effect size (ES) of 0.79; for
apnea-hypopnea index/h (base at 11.5, SD 5)19 participants are required for a ES of
0.7. For subjective reports of snoring intensity (9 participants are required; ES of
1.11), however, an article reported significant results with 18 subjects. [20] A
final sample of 20-22 subjects is targeted. These estimates are comparable to those
in our previous orthotic studies of bruxism and OSA populations done by our group
members.
- Types of data and collection: After completing the consent, the participant will be
asked to complete demographic, sleep and basic medical information. It will be built
from validated questionnaires estimating quality of life (SF-12), sleep (PSQI),
sleepiness (Epworth), risk of apnea (Stop Bang), fatigue (Chalder), and orofacial
pain. The data will be entered via WEB (REDCap) and saved on the CHUM/CITADELLE
server. Following the 3 home sleep recordings, paticipants will assess on
questionnaire their perception of change in sleep quality based on the validated
scales used in our previous studies on apnea and MAD. In addition, the comfort of
MAD (tolerance) and the perception of the spouse will also be estimated as in our
previous studies. The quantitative home sleep data, namely duration and snoring
indexes, apnea-hypopnea, instability and sleep duration, will be calculated, as
already published, by the measurements obtained (breathing, oxygen saturation, sleep
position, pulse, snoring) with the ambulatory recording instruments (Alice TM,
Philips, USA) from CHUM sleep laboratory and analyzed by qualified technical staff.
Qualitative data on MAD treatment expectations and oral health experiences related
to POC (chewing, pain) will be estimated in a subgroup of participants (n=15),
before and after MAD treatment. This will be done by a semi-structured interview.
- Statistics and design for analysis: Like sleep analyses, the results will be
analyzed blindly with the following tests: 1) parametric tests such as: t-test for
inter-group comparisons, linear mixed models and linear mixed models for repeated
measurements, followed by contrasts for post-hoc comparisons where appropriate using
the Tukey method (SPSS software); 2) nonparametric tests such as chi-square,
Mann-Whitney and non-parametric ANOVA for repeated measurements followed by
contrasts for post-hoc comparisons where appropriate using the Tukey method (for
category data and/or when the data distribution does not correspond to a normal
distribution); 3) correlation tests, such as Pearson's or Spearman's correlation
coefficient, if applicable. A biostatistician will oversee the analyses. Qualitative
data will be analyzed to extract recurring themes from transcripts of verbatims
using software, N*VIVO. The collection of themes will be done until saturation. The
software allows data coding and categorization for final analysis .
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHUM
Address:
City:
Montréal
Zip:
H3X 3E4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Karine Peaupert
Phone:
514-890-8000
Phone ext:
14730
Start date:
February 3, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Centre hospitalier de l'Université de Montréal (CHUM)
Agency class:
Other
Source:
Centre hospitalier de l'Université de Montréal (CHUM)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05719779
