Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Sleep Apnea
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 79 years
Gender
Both males and females

Description

The primary goal of the current study is to determine the effect of combination therapy targeting phenotypic traits on OSA severity. Specifically, the investigators will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index and the arousal i...

The primary goal of the current study is to determine the effect of combination therapy targeting phenotypic traits on OSA severity. Specifically, the investigators will assess the effect of combination pharmacological therapy on OSA severity as measured by the apnea-hypopnea index and the arousal index (co-primary outcome variables). The investigators will also estimate the effects of the interventions on the physiological traits responsible for OSA using polysomnography, namely: Pharyngeal anatomy and its propensity towards collapse The ability of the upper airway dilator muscles to activate and reopen the airway during sleep (i.e. neuromuscular compensation) Arousal threshold from sleep (i.e. the propensity for hypopneas/apneas to lead to arousal and fragmented sleep). Stability of the ventilatory control system feedback loop (i.e. loop gain). Baseline traits will be used to examine whether patient characteristics influence the responses to each combination of interventions (i.e. muscles, muscles plus loop gain, muscles plus arousal threshold).

Tracking Information

NCT #
NCT03892772
Collaborators
Apnimed
Investigators
Principal Investigator: Scott A Sands, PhD Brigham and Women's Hospital Principal Investigator: Bradley A Edwards, PhD Monash University