Pharmacological Activation of HMN for OSA Aim 2

Phase 1

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: LTM1201AD; Drug: Placebo oral capsule; Drug: LTM1201AZ; Drug: LTM1201AG; Drug: LTM1201AT

• Registration Number: NCT03858751
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study Start: 2019-03-01
• Study First Posted: 2019-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LTM1201AD	LTM1201AD	LTM1201AD capsule before bedtime
Placebo	Placebo oral capsule	Placebo capsule before bedtime
LTM1201AZ	LTM1201AZ	LTM1201AZ capsule before bedtime
LTM1201AG	LTM1201AG	LTM1201AG capsule before bedtime
LTM1201AT	LTM1201AT	LTM1201AT capsule before bedtime

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)	3 nights (treatment duration)	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States