Airway Muscle Activation on Sleep-disordered Breathing Events

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 24, 2023

Primary Completion Date

July 31, 2024

Study Completion Date

July 31, 2024

Conditions
Sleep Apnea
Interventions
DEVICE

NovaResp MAPR System

"Baseline measurements will be taken while the subject is awake. Genioglossus activity with maximal tongue protrusion will be measured as well as the response to 1 to 2 pressure routines. Once the subject is sleeping, the operator will observe the PSG recording and determine sleep stage and respiratory phase (inspiration, expiration, between breaths). Test routines will be performed for each sleep stage and each respiratory phase. If the operator notices an apnea occurring, one of the routines will be applied. When all manual tests are complete, an automatic mode will be engaged for the remainder of the night. During this mode, a previously developed and trialled AI model will be used to predict if an obstructive apnea is upcoming. The operator will input which routine to test, and the routine will be automatically applied when a prediction occurs. There will be a minimum of 60 seconds between pressure routine applications."

Trial Locations (1)

B3H 2E2

RECRUITING

Sleep Disorders Clinic, Halifax

Sponsors
All Listed Sponsors
lead

NovaResp Technologies Inc

INDUSTRY

NCT06002061 - Airway Muscle Activation on Sleep-disordered Breathing Events | Biotech Hunter | Biotech Hunter