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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03858751
Other study ID # 2018p001201aim2
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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%

Study Design


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)
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