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Pharmacological Agent

Pharmacological Activation of HMN for OSA Aim 2

Phase 1 & 2
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* AHI \> 10 events/h during NREM supine sleep
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 nights (treatment duration)

Summary

This trial is testing different medications given before sleep to help patients with obstructive sleep apnea. These patients have weak throat muscles when they fall asleep, causing their airways to collapse. The medications aim to keep these muscles active during sleep to prevent this collapse. Initial findings in a study of 73 adults with moderate or severe OSA reported that the cannabinoid, dronabinol, reduced the number of airway collapse events per hour from 25.9 to 15.2 (2.5 mg dose) and 13.0 (10 mg dose).

Eligible Conditions
  • Obstructive Sleep Apnea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 nights (treatment duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 nights (treatment duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apnea hypopnea Index (AHI, average number of events for every hour of sleep)

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: LTM1201AZExperimental Treatment1 Intervention
LTM1201AZ capsule before bedtime
Group II: LTM1201ATExperimental Treatment1 Intervention
LTM1201AT capsule before bedtime
Group III: LTM1201AGExperimental Treatment1 Intervention
LTM1201AG capsule before bedtime
Group IV: LTM1201ADExperimental Treatment1 Intervention
LTM1201AD capsule before bedtime
Group V: PlaceboPlacebo Group1 Intervention
Placebo capsule before bedtime

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,450 Total Patients Enrolled
~2 spots leftby Dec 2025
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