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Pharmacological Activation of HMN for OSA (OSA12)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
LTM1201L
LTM1201LN
LTM1201LB
LTM1201LD
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Brigham and Women's Hospital
  • Sleep Disorders Research Program Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

LTM1201L

LTM1201LN

LTM1201LB

LTM1201LD

Arm Description

Placebo capsule 1 time before bedtime

LTM1201L capsule 1 time before bedtime

LTM1201LN capsule 1 time before bedtime

LTM1201LB capsule 1 time before bedtime

LTM1201LD capsule 1 time before bedtime

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
August 17, 2018
Last Updated
February 11, 2020
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03640052
Brief Title
Pharmacological Activation of HMN for OSA
Acronym
OSA12
Official Title
Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule 1 time before bedtime
Arm Title
LTM1201L
Arm Type
Active Comparator
Arm Description
LTM1201L capsule 1 time before bedtime
Arm Title
LTM1201LN
Arm Type
Active Comparator
Arm Description
LTM1201LN capsule 1 time before bedtime
Arm Title
LTM1201LB
Arm Type
Active Comparator
Arm Description
LTM1201LB capsule 1 time before bedtime
Arm Title
LTM1201LD
Arm Type
Active Comparator
Arm Description
LTM1201LD capsule 1 time before bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201L
Intervention Description
LTM1201L capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201LN
Intervention Description
LTM1201LN capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201LB
Intervention Description
LTM1201LB capsule before sleep
Intervention Type
Drug
Intervention Name(s)
LTM1201LD
Intervention Description
LTM1201LD capsule before sleep
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)
Description
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.
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Collapsibility of the Upper Airway: VActive (L/Min)
Description
VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Sleep Disorders Research Program Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacological Activation of HMN for OSA

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