Mechanisms of Upper Airway Obstruction

NACompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

June 3, 2020

Primary Completion Date

May 10, 2024

Study Completion Date

May 10, 2024

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

Lingual Muscle Stimulation

Tongue protrudor muscles will be stimulated

OTHER

Mandibular advancement

Outcome variables will be assess with and without mandibular advancement

OTHER

Postural maneuvers

Outcome variables will be measured with and without postural maneuvers

OTHER

Digital Morphometrics

A digital camera with laser pointers will be used to capture a series of craniofacial photographs (frontal, profile and neck extended) and intra-oral photographs (junction of the hard and soft palate, airway, or base of tongue).

OTHER

Tongue Force Exercise

The patient will place a small bulb behind their lower incisors and will press using their tongue as hard as possible for two seconds. This exercise will be repeated four times, with 30 seconds of rest in between each attempt. The patient will then be instructed to press and hold their tongue against the bulb as hard as possible for 35 seconds. This exercise will be repeated three times, with 2 minutes of rest in between each attempt.

OTHER

Magnetic resonance imaging (MRI)

The patient will undergo an MRI scan of the head and neck.

OTHER

Polysomnography (PSG) - Split Night

The patient will undergo a polysomnography (PSG). The PSG study will include monitoring of EEG, submental EMG, EOG, SpO2, tidal airflow, thoraco-abdominal efforts, and body position. The patient will spend half of the night at baseline (i.e. no intervention), and the second half with lingual muscle stimulation activated.

Trial Locations (1)

19104

Hospital of the University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER

NCT04322097 - Mechanisms of Upper Airway Obstruction | Biotech Hunter | Biotech Hunter