RecruitingPhase 1Phase 2NCT03858751

Pharmacological Activation of HMN for OSA Aim 2

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


Sponsor

Brigham and Women's Hospital

Enrollment

16 participants

Start Date

Mar 1, 2019

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

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%

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPlacebo oral capsule

Placebo capsule before bedtime

DRUGLTM1201AZ

LTM1201AZ oral capsule before sleep

DRUGLTM1201AT

LTM1201AT oral capsule before sleep

DRUGLTM1201AG

LTM1201AG oral capsule before sleep

DRUGLTM1201AD

LTM1201AD oral capsule before sleep


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03858751


Related Trials