Pharmacological Activation of HMN for OSA Aim 2
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
LTM1201AZ
LTM1201AT
LTM1201AG
LTM1201AD
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility 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%
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
LTM1201AZ
LTM1201AT
LTM1201AG
LTM1201AD
Arm Description
Placebo capsule before bedtime
LTM1201AZ capsule before bedtime
LTM1201AT capsule before bedtime
LTM1201AG capsule before bedtime
LTM1201AD capsule before bedtime
Outcomes
Primary Outcome Measures
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
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
Full Information
NCT ID
NCT03858751
First Posted
February 27, 2019
Last Updated
September 19, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03858751
Brief Title
Pharmacological Activation of HMN for OSA Aim 2
Official Title
Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule before bedtime
Arm Title
LTM1201AZ
Arm Type
Experimental
Arm Description
LTM1201AZ capsule before bedtime
Arm Title
LTM1201AT
Arm Type
Experimental
Arm Description
LTM1201AT capsule before bedtime
Arm Title
LTM1201AG
Arm Type
Experimental
Arm Description
LTM1201AG capsule before bedtime
Arm Title
LTM1201AD
Arm Type
Experimental
Arm Description
LTM1201AD capsule before bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo capsule before bedtime
Intervention Type
Drug
Intervention Name(s)
LTM1201AZ
Intervention Description
LTM1201AZ oral capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201AT
Intervention Description
LTM1201AT oral capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201AG
Intervention Description
LTM1201AG oral capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201AD
Intervention Description
LTM1201AD oral capsule before sleep
Primary Outcome Measure Information:
Title
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)
Description
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.
Time Frame
3 nights (treatment duration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Calianese, Research Assistant
Phone
617-732-8977
Email
ncalianese@partners.org
First Name & Middle Initial & Last Name & Degree
Lauren Hess, RPSGT
Phone
617-732-8976
Email
lhess1@bwh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Pharmacological Activation of HMN for OSA Aim 2
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