NCT03640052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

August 17, 2018

Results QC Date

January 28, 2020

Last Update Submit

February 11, 2020

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 night

Secondary Outcomes (1)

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

    1 night

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo capsule 1 time before bedtime

Drug: Placebo oral capsule

LTM1201L

ACTIVE COMPARATOR

LTM1201L capsule 1 time before bedtime

Drug: LTM1201L

LTM1201LN

ACTIVE COMPARATOR

LTM1201LN capsule 1 time before bedtime

Drug: LTM1201LN

LTM1201LB

ACTIVE COMPARATOR

LTM1201LB capsule 1 time before bedtime

Drug: LTM1201LB

LTM1201LD

ACTIVE COMPARATOR

LTM1201LD capsule 1 time before bedtime

Drug: LTM1201LD

Interventions

Placebo oral capsuleDRUG

Placebo capsule before sleep

Placebo
LTM1201LDRUG

LTM1201L capsule before sleep

LTM1201L
LTM1201LNDRUG

LTM1201LN capsule before sleep

LTM1201LN
LTM1201LBDRUG

LTM1201LB capsule before sleep

LTM1201LB
LTM1201LDDRUG

LTM1201LD capsule before sleep

LTM1201LD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI \> 10 events/h during NREM supine sleep

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Luigi Taranto Montemurro, MD
Organization
Brigham and Women's Hospital
ltarantomontemurro@bwh.harvard.edu
6177326541

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

October 30, 2018

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

February 24, 2020

Results First Posted

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)