Pharmacological Activation of HMN for OSA Aim 2

Mass General Brigham

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obstructive Sleep Apnea

Treatments: Drug: LTM1201AD; Drug: LTM1201AT; Drug: Placebo oral capsule; Drug: LTM1201AZ; Drug: LTM1201AG

Study type: Interventional

Funder types: Other

Identifiers

NCT03858751

2018p001201aim2

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsule before bedtime

Treatment:

Drug: Placebo oral capsule

LTM1201AZ

Experimental group

Description:

LTM1201AZ capsule before bedtime

Treatment:

Drug: LTM1201AZ

LTM1201AT

Experimental group

Description:

LTM1201AT capsule before bedtime

Treatment:

Drug: LTM1201AT

LTM1201AG

Experimental group

Description:

LTM1201AG capsule before bedtime

Treatment:

Drug: LTM1201AG

LTM1201AD

Experimental group

Description:

LTM1201AD capsule before bedtime

Treatment:

Drug: LTM1201AD