Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03892772

Run by

Brigham and Women's Hospital

People needed

23

Starts

2019-01-14

Expected to finish

2021-07-03

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18 - 79 years
• Suspected or diagnosed OSA

You may not qualify if…

• Any uncontrolled medical condition
• Current use of the medications under investigation
• Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
• Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines).
• Current use of SNRIs/SSRIs or anticholinergic medications.
• Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
• Respiratory disorders other than sleep disordered breathing:
• chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
• Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
• Contraindications for SAS0421a and SAS0421b, including:
• hypersensitivity to SAS0421a and SAS0421b (angioedema or urticaria)
• pheochromocytoma
• use of monoamine oxidase inhibitors
• benign prostatic hypertrophy, urinary retention
• untreated narrow angle glaucoma
• bipolar disorder, mania, psychosis
• history of major depressive disorder (age<24).
• history of attempted suicide or suicidal ideation within one year prior to screening
• clinically significant constipation, gastric retention
• pre-existing seizure disorders
• clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2)
• clinically-significant liver disorders
• clinically-significant cardiovascular conditions
• severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline)
• cardiomyopathy (LVEF<50%) or heart failure

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Monash University — Clayton, Victoria, Australia

Full record on ClinicalTrials.gov

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