Pharmacological Activation of HMN for OSA Aim 2

NCT03858751 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-09-21

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-11-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858751 on ClinicalTrials.gov