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Pharmacological Activation of HMN for OSA (OSA12)

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ClinicalTrials.gov Identifier: NCT03640052
Recruitment Status : Completed
First Posted : August 21, 2018
Results First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Luigi Taranto Montemurro, Brigham and Women's Hospital

Study Description
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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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD 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: LTM1201L Drug: LTM1201LN Drug: LTM1201LB Drug: LTM1201LD Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule 1 time before bedtime
 Drug: Placebo oral capsule
Placebo capsule before sleep
Active Comparator: LTM1201L
LTM1201L capsule 1 time before bedtime
 Drug: LTM1201L
LTM1201L capsule before sleep
Active Comparator: LTM1201LN
LTM1201LN capsule 1 time before bedtime
 Drug: LTM1201LN
LTM1201LN capsule before sleep
Active Comparator: LTM1201LB
LTM1201LB capsule 1 time before bedtime
 Drug: LTM1201LB
LTM1201LB capsule before sleep
Active Comparator: LTM1201LD
LTM1201LD capsule 1 time before bedtime
 Drug: LTM1201LD
LTM1201LD capsule before sleep


Outcome Measures
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Primary Outcome Measures :
  1. Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep) [ Time Frame: 1 night ]
    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.


Secondary Outcome Measures :
  1. Collapsibility of the Upper Airway: VActive (L/Min) [ Time Frame: 1 night ]
    VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.


Eligibility Criteria
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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%
Contacts and Locations
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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): NCT03640052


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Luigi Taranto Montemurro, Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] December 6, 2018

More Information
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Responsible Party: Luigi Taranto Montemurro, Principal investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03640052    
Other Study ID Numbers: 2018P001201
First Posted: August 21, 2018    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020
Last Verified: February 2020
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