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Pharmacological Activation of HMN for OSA Aim 2

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ClinicalTrials.gov Identifier: NCT03858751
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Luigi Taranto Montemurro, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Placebo oral capsule Drug: LTM1201AZ Drug: LTM1201AT Drug: LTM1201AG Drug: LTM1201AD Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule before bedtime
Drug: Placebo oral capsule
Placebo capsule before bedtime

Experimental: LTM1201AZ
LTM1201AZ capsule before bedtime
Drug: LTM1201AZ
LTM1201AZ oral capsule before sleep

Experimental: LTM1201AT
LTM1201AT capsule before bedtime
Drug: LTM1201AT
LTM1201AT oral capsule before sleep

Experimental: LTM1201AG
LTM1201AG capsule before bedtime
Drug: LTM1201AG
LTM1201AG oral capsule before sleep

Experimental: LTM1201AD
LTM1201AD capsule before bedtime
Drug: LTM1201AD
LTM1201AD oral capsule before sleep




Primary Outcome Measures :
  1. Apnea hypopnea Index (AHI, average number of events for every hour of sleep) [ Time Frame: 3 nights (treatment duration) ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858751


Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicole Calianese, Research Assistant    617-732-8977    ncalianese@partners.org   
Contact: Lauren Hess, RPSGT    617-732-8976    lhess1@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital

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Responsible Party: Luigi Taranto Montemurro, Principal investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03858751     History of Changes
Other Study ID Numbers: 2018p001201aim2
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases