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Recruiting Phase 1, Phase 2 NCT03858751

Pharmacological Activation of HMN for OSA Aim 2

Trial Parameters

Condition Obstructive Sleep Apnea
Sponsor Brigham and Women's Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 16
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2019-03-01
Completion 2022-11-30
Interventions
Placebo oral capsuleLTM1201AZLTM1201AT

Brief Summary

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.

Eligibility Criteria

Inclusion Criteria: * AHI \> 10 events/h during NREM supine sleep Exclusion Criteria: * Any medical condition other than well controlled hypertension and mild diabetes. * Any medication known to influence breathing, sleep/arousal, or muscle physiology. * Claustrophobia. * Inability to sleep supine. * Allergy to any of the medications tested in the protocol. * History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D. * Individuals with underlying cardiac disease, such as arrhythmias. * Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care. * For women: Pregnancy. * Pulmonary hypertension * Severe OSA with a mean SaO2 lower than 88%

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