NCT03892772

Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Currently, there is no pharmacological intervention for OSA that targets multiple pathophysiological deficits in combination. Here the investigators study the effect on sleep apnea severity of combinations of pharmacological agents that stimulate the pharyngeal muscles, stabilize ventilatory control, and increase the arousal threshold.

Detailed 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 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).

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DRUG	SAS0421a	treatment will be given for 3 days
DRUG	SAS0421b	treatment will be given for 3 days
DRUG	SAS0421c	treatment will be given for 3 days
DRUG	placebo	placebo will be given for 3 days

Timeline

• Start date: 2019-01-14
• Primary completion: 2021-07-03
• Completion: 2021-07-03
• First posted: 2019-03-27
• Last updated: 2022-03-02

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study