Pharmacological Activation of HMN for OSA Aim 2
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 21, 2022
September 1, 2022
3.8 years
February 27, 2019
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 nights (treatment duration)
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo capsule before bedtime
LTM1201AZ
EXPERIMENTALLTM1201AZ capsule before bedtime
LTM1201AT
EXPERIMENTALLTM1201AT capsule before bedtime
LTM1201AG
EXPERIMENTALLTM1201AG capsule before bedtime
LTM1201AD
EXPERIMENTALLTM1201AD capsule before bedtime
Interventions
Eligibility Criteria
You may qualify if:
- AHI \> 10 events/h during NREM supine sleep
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 1, 2019
Study Start
March 1, 2019
Primary Completion
November 30, 2022
Study Completion
December 31, 2022
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share