Pharmacological Activation of HMN for OSA

Phase 1

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: LTM1201LN; Drug: LTM1201LD; Drug: Placebo oral capsule; Drug: LTM1201L; Drug: LTM1201LB

• Registration Number: NCT03640052
• Lead Sponsor: Brigham and Women's Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-10-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31
• Results First Submitted: 2020-01-28
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Results First Posted: 2020-02-24
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LTM1201LN	LTM1201LN	LTM1201LN capsule 1 time before bedtime
LTM1201LD	LTM1201LD	LTM1201LD capsule 1 time before bedtime
Placebo	Placebo oral capsule	Placebo capsule 1 time before bedtime
LTM1201L	LTM1201L	LTM1201L capsule 1 time before bedtime
LTM1201LB	LTM1201LB	LTM1201LB capsule 1 time before bedtime

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)	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 Outcome Measures

Name	Time	Method
Collapsibility of the Upper Airway: VActive (L/Min)	1 night	VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Sleep Disorders Research Program Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States