Pharmacological Activation of HMN for OSA Aim 2

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858751
• Other study ID #: 2018p001201aim2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea hypopnea Index (AHI, average number of events for every hour of sleep)	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.	3 nights (treatment duration)