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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Placebo capsule before bedtime
  • Drug: Placebo oral capsule
    Placebo capsule before bedtime
Experimental
LTM1201AZ 		LTM1201AZ capsule before bedtime
  • Drug: LTM1201AZ
    LTM1201AZ oral capsule before sleep
Experimental
LTM1201AT 		LTM1201AT capsule before bedtime
  • Drug: LTM1201AT
    LTM1201AT oral capsule before sleep
Experimental
LTM1201AG 		LTM1201AG capsule before bedtime
  • Drug: LTM1201AG
    LTM1201AG oral capsule before sleep
Experimental
LTM1201AD 		LTM1201AD capsule before bedtime
  • Drug: LTM1201AD
    LTM1201AD oral capsule before sleep

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Nicole Calianese, Research Assistant
617-732-8977
ncalianese@partners.org

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.