Pharmacological Activation of HMN for OSA

Brigham and Women's Hospital6 enrolled

Overview

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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Placebo oral capsuleDRUG

Placebo capsule before sleep

LTM1201LDRUG

LTM1201L capsule before sleep

LTM1201LNDRUG

LTM1201LN capsule before sleep

LTM1201LB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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%

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)

Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive \>50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.

Time frame: 1 night

Secondary Outcomes

Collapsibility of the Upper Airway: VActive (L/Min)

VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.

Time frame: 1 night

Data from ClinicalTrials.gov

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