Pharmacological Activation of HMN for OSA

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2019-12-31

Brief Summary

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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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Placebo

Placebo capsule 1 time before bedtime

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo capsule before sleep

LTM1201L

LTM1201L capsule 1 time before bedtime

Group Type ACTIVE_COMPARATOR

LTM1201L

Intervention Type DRUG

LTM1201L capsule before sleep

LTM1201LN

LTM1201LN capsule 1 time before bedtime

Group Type ACTIVE_COMPARATOR

LTM1201LN

Intervention Type DRUG

LTM1201LN capsule before sleep

LTM1201LB

LTM1201LB capsule 1 time before bedtime

Group Type ACTIVE_COMPARATOR

LTM1201LB

Intervention Type DRUG

LTM1201LB capsule before sleep

LTM1201LD

LTM1201LD capsule 1 time before bedtime

Group Type ACTIVE_COMPARATOR

LTM1201LD

Intervention Type DRUG

LTM1201LD capsule before sleep

Interventions

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Placebo oral capsule

Placebo capsule before sleep

Intervention Type DRUG

LTM1201L

LTM1201L capsule before sleep

Intervention Type DRUG

LTM1201LN

LTM1201LN capsule before sleep

Intervention Type DRUG

LTM1201LB

LTM1201LB capsule before sleep

Intervention Type DRUG

LTM1201LD

LTM1201LD capsule before sleep

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No