Pharmacological Activation of HMN for OSA Aim 2
Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
Brigham and Women's Hospital
16 participants
Mar 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- AHI > 10 events/h during NREM supine sleep
Exclusion Criteria11
- 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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Interventions
Placebo capsule before bedtime
LTM1201AZ oral capsule before sleep
LTM1201AT oral capsule before sleep
LTM1201AG oral capsule before sleep
LTM1201AD oral capsule before sleep
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03858751