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Study of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG for Obstructive Sleep Apnea

This study is looking into new ways to treat Obstructive Sleep Apnea (OSA), a common condition where breathing repeatedly stops and starts during sleep. Researchers are testing four different oral capsules: LTM1201AZ, LTM1201AT, LTM1201AD, and LTM1201AG, taken before bedtime, compared to a placebo (an inactive capsule). The goal is to see if these medications can help reduce the severity of OSA by improving how your upper airway muscles work during sleep. They will measure the Apnea Hypopnea Index (AHI), which is the average number of breathing pauses per hour of sleep, after three nights of treatment. You may be able to join if you are between 18 and 70 years old, have an AHI greater than 10 during NREM supine sleep, and do not have certain medical conditions or allergies to the study drugs. The study aims to enroll 16 participants, but its current status is unclear.

Study design
This study is testing different oral capsules against a placebo in 16 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Apnea Hypopnea Index, is measured after three nights of treatment, which suggests a short follow-up period during treatment.

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NCT03858751

Pharmacological Activation of HMN for OSA Aim 2

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Brigham and Women's Hospital
~16 participants
Updated 2022-09-21 on ClinicalTrials.gov
What's tested:Placebo oral capsuleLTM1201AZLTM1201ATLTM1201AGLTM1201AD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
Measured over 3 nights (treatment duration)

Conditions

Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Nicole Calianese, Research Assistant
[email protected]
617-732-8977
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

AHI \> 10 events/h during NREM supine sleep

Exclusion

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%

What this trial measures

  • 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.