Pharmacological Activation of HMN for OSA Aim 2

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03858751
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo oral capsule — DRUG
    Placebo capsule before bedtime
  • LTM1201AZ — DRUG
    LTM1201AZ oral capsule before sleep
  • LTM1201AT — DRUG
    LTM1201AT oral capsule before sleep
  • LTM1201AG — DRUG
    LTM1201AG oral capsule before sleep
  • LTM1201AD — DRUG
    LTM1201AD oral capsule before sleep

Study Details

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.

Key Dates

Start date
Mar 1, 2019
Status verified
Sep 2022
Primary completion
Nov 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo capsule before bedtime
  • Experimental: LTM1201AZ
    LTM1201AZ capsule before bedtime
  • Experimental: LTM1201AT
    LTM1201AT capsule before bedtime
  • Experimental: LTM1201AG
    LTM1201AG capsule before bedtime
  • Experimental: LTM1201AD
    LTM1201AD capsule before bedtime

Primary Outcome Measure

Apnea hypopnea Index (AHI, average number of events for every hour of sleep) [ Time Frame: 3 nights (treatment duration) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Nicole Calianese, Research Assistant
[email protected]
617-732-8977
Lauren Hess, RPSGT
[email protected]
617-732-8976

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By research site
Brigham and Women's Hospital· Boston, MA

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