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NCT03858751 · ClinicalTrials.gov registry record · Phase 1
Pharmacological Activation of HMN for OSA Aim 2
A Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03858751: Recruiting Phase 1 study of Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital.
NCT03858751 is a Phase 1 study of Obstructive Sleep Apnea that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858751, a Phase 1 study of Obstructive Sleep Apnea, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG LTM1201AZ
- DRUG LTM1201AT
- DRUG LTM1201AG
- DRUG LTM1201AD
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
What NCT03858751 shows while recruiting
NCT03858751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 5 interventions - of which Placebo oral capsule is the first listed.
NCT03858751 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03858751 about?
NCT03858751 is a clinical study titled "Pharmacological Activation of HMN for OSA Aim 2". 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 th...
What is the current status of trial NCT03858751?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-03-01. Estimated completion is 2022-12-31.
What conditions does trial NCT03858751 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT03858751?
The interventions under investigation include: Placebo oral capsule (DRUG), LTM1201AZ (DRUG), LTM1201AT (DRUG), LTM1201AG (DRUG), LTM1201AD (DRUG).
Who is sponsoring clinical trial NCT03858751?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03858751 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03858751's enrollment target sits among peer trials
16 148th of 155 higher than 8 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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