Pharmacological Activation of HMN for OSA Aim 2

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03858751

Enrollment

Registered

2019-03-01

Start date

2019-03-01

Completion date

2022-12-31

Last updated

2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026