Pharmacological Activation of HMN for OSA Aim 2

NCT ID: NCT03858751

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-12-31

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 LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule before bedtime

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo capsule before bedtime

LTM1201AZ

LTM1201AZ capsule before bedtime

Group Type EXPERIMENTAL

LTM1201AZ

Intervention Type DRUG

LTM1201AZ oral capsule before sleep

LTM1201AT

LTM1201AT capsule before bedtime

Group Type EXPERIMENTAL

LTM1201AT

Intervention Type DRUG

LTM1201AT oral capsule before sleep

LTM1201AG

LTM1201AG capsule before bedtime

Group Type EXPERIMENTAL

LTM1201AG

Intervention Type DRUG

LTM1201AG oral capsule before sleep

LTM1201AD

LTM1201AD capsule before bedtime

Group Type EXPERIMENTAL

LTM1201AD

Intervention Type DRUG

LTM1201AD oral capsule before sleep

Interventions

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Placebo oral capsule

Placebo capsule before bedtime

Intervention Type DRUG

LTM1201AZ

LTM1201AZ oral capsule before sleep

Intervention Type DRUG

LTM1201AT

LTM1201AT oral capsule before sleep

Intervention Type DRUG

LTM1201AG

LTM1201AG oral capsule before sleep

Intervention Type DRUG

LTM1201AD

LTM1201AD oral 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

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Scott Aaron Sands

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Nicole Calianese, Research Assistant

Role: primary

617-732-8977

Lauren Hess, RPSGT

Role: backup

617-732-8976

Other Identifiers

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2018p001201aim2

Identifier Type: -

Identifier Source: org_study_id

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