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Completed

NCT Number: NCT03640052

Pharmacological Activation of HMN for OSA

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 LTM1201L, LTM1201LN, LTM1201LB, LTM1201LD administered before sleep on OSA phenotype traits and OSA severity during sleep.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Placebo oral capsule

Drug

Placebo capsule before sleep

LTM1201L

Drug

LTM1201L capsule before sleep

LTM1201LN

Drug

LTM1201LN capsule before sleep

LTM1201LB

Drug

LTM1201LB capsule before sleep

LTM1201LD

Drug

LTM1201LD capsule before sleep

Primary outcomes

  1. Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)

    Time frame: 1 night

    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.

Secondary outcomes

  1. Collapsibility of the Upper Airway: VActive (L/Min)

    Time frame: 1 night

    VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea

Acronym: OSA12

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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