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Recruiting NCT03858751

Pharmacological Activation of HMN for OSA Aim 2

Phase I / Phase II Interventional Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo oral capsule, LTM1201AZ, LTM1201AT, LTM1201AG.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2

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 LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.

Interventions

  • Drug Placebo oral capsule
    Placebo capsule before bedtime
  • Drug LTM1201AZ
    LTM1201AZ oral capsule before sleep
  • Drug LTM1201AT
    LTM1201AT oral capsule before sleep
  • Drug LTM1201AG
    LTM1201AG oral capsule before sleep
  • Drug LTM1201AD
    LTM1201AD oral capsule before sleep

Primary outcome measures

  • Apnea hypopnea Index (AHI, average number of events for every hour of sleep) [Time frame: 3 nights (treatment duration)]

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT03858751 · 2018p001201aim2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗