Predictive Factors for Prescribing a Mandibular Advancement Device for the Treatment of Obstructive Sleep Apnea

UnknownOBSERVATIONAL
Enrollment

66

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

October 31, 2023

Study Completion Date

December 31, 2023

Conditions
Sleep Apnea, Obstructive
Interventions
RADIATION

Pharyngeal Computed Tomography

To assess the presence of a possible level/level of collapse, a pharyngeal CT with cephalometry will be performed, and a standard classification system, VOTE, will be used. After obtaining said CT, the dentist will place the recording in MCP and perform a new CT scan of the pharynx with cephalometry and with the MCP recording set intraorally to assess whether this position reduces or eliminates the collapse from UA.

DRUG

Drug-Induced Sleep Endoscopy (Propofol)

The DISE technique will be performed by an otorhinolaryngologist (ENT) with a nasopharyngoscope in a operating room. This technique is complemented with bite registration (MCP). Artificial sleep will be induced by intravenous administration of propofol through an infusion system controlled by an anesthesiologist (2.0-3.0 mcg/mL). The following variables will be continuously monitored: electrocardiography, oxygen saturation, and bispectral index (BIS). In this phase of the DISE, the upper airways will be evaluated during sleep with the MCP positioned intra-orally.

DEVICE

Mandibular Advancement Device

A duo-block, titratable, and customized MAD (NOA®; Orthoapnea) will be fitted for each patient who starts treatment with MAD. The MAD consists of two CAD/CAM polyamide intraoral devices (one for the upper and one for the lower arch). The adaptation period takes place over one month. After this adaptation, patients will undergo a new PSG using MAD.

Trial Locations (1)

1350-352

CUF Tejo Hospital, Lisbon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CUF Tejo Hospital

UNKNOWN

collaborator

Orthoapnea

UNKNOWN

lead

Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER