Clinical trial · Interventional
Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Oropharyngeal Cancer.
Evaluation of the Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Patients With Oropharyngeal Cancer: Mixed Design Study.
NCT05719779CI-TRIAL-00079838Ronco-OncounknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Pharynx Cancer | Malignant Pharyngeal Neoplasm | CURATED_BROADER | 0.80 |
| Sleep Apnea | — | UNRESOLVED | — |
| Snoring | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ronco-Onco and MAD | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MAD-active
- description
- MAD = mandibular advancement appliance, in 60-70% forward position from maximum possible jaw advancement for a given participant
- interventionNames
- Device: Ronco-Onco and MAD
- type
- SHAM_COMPARATOR
- label
- Neutral MAD- control
- description
- Mandibular advancement appliance in neurtral-control position, 10-20% of advancement - a non functional position to open upper airway
- interventionNames
- Device: Ronco-Onco and MAD
Primary outcomes (2)
- measure
- Index apnea-hypopnea
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (1)
- BACKGROUNDDal 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