Recruiting
Phase 1
Phase 2

HMN

Sponsor:

Brigham and Women's Hospital

Code:

NCT03858751

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Placebo oral capsule

LTM1201AZ

LTM1201AT

LTM1201AG

LTM1201AD

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT03858751

Start date

Mar 1, 2019

Status verified date

Sep, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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%

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Placebo oral capsule

Placebo capsule before bedtime

LTM1201AZ

LTM1201AZ oral capsule before sleep

LTM1201AT

LTM1201AT oral capsule before sleep

LTM1201AG

LTM1201AG oral capsule before sleep

LTM1201AD

LTM1201AD oral capsule before sleep

Primary outcome measure

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

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Nicole Calianese, Research Assistant

617-732-8977ncalianese@partners.org

Lauren Hess, RPSGT

617-732-8976lhess1@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 21, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2022-09-21.