Pharmacological Activation of HMN for OSA | NCT03640052

Pharmacological Activation of HMN for OSA | NCT03640052 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo oral capsule	Drug	Placebo capsule before sleep	Placebo
LTM1201L

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States
Sleep Disorders Research Program Brigham and Women's Hospital

Arm/Group Information

ID	Title	Description
FG000	Placebo First	Placebo administered before sleep for 1 night, followed by LTM1201L, LTM1201LD, LTM1201LN and LTM1201LB, administered 1 week apart in the hospital
FG001	LTM1201L First	LTM1201L administered before sleep for 1 night, followed by LTM1201LD, LTM1201LN, LTM1201LB and Placebo, administered 1 week apart in the hospital
FG002	LTM1201LD First	LTM1201LD administered before sleep for 1 night, followed by LTM1201LN, LTM1201LB, Placebo and LTM1201L, administered 1 week apart in the hospital
FG003	LTM1201LN First	LTM1201LN administered before sleep for 1 night, followed by LTM1201LB, Placebo, LTM1201L and LTM1201LD administered 1 week apart in the hospital
FG004	LTM1201LB First	LTM1201LB administered before sleep for 1 night, followed by Placebo, LTM1201L, LTM1201LD and LTM1201LN administered 1 week apart in the hospital

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0002 subjects FG0011 subjects FG0021 subjects FG0031 subjects FG0041 subjects
COMPLETED		FG0002 subjects FG0010 subjectsthe patient performed 4 out of 5 nights FG0021 subjects FG0031 subjects
NOT COMPLETED		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0011 subjects FG0020 subjects FG003

Baseline Characteristics Module

ID	Title	Description
BG000	All Analyzed Participants	All participants who were randomized, completed both study nights, and were included in the analysis.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Error

events/hour of sleep

1 night

ID	Title	Description
OG000	Placebo	Placebo capsule 1 time before bedtime Placebo oral capsule: Placebo capsule before sleep
OG001	LTM1201L	LTM1201L capsule 1 time before bedtime LTM1201L: LTM1201L capsule before sleep

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo capsule 1 time before bedtime Placebo oral capsule: Placebo capsule before sleep

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Dry mouth	Skin and subcutaneous tissue disorders		Non-systematic Assessment	Dry mouth

More Info Module

Certain Agreements

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

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 6, 2018	Jan 28, 2020	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D020181	Sleep Apnea, Obstructive

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0001
White	BG0005
More than one race	BG0000
Unknown or Not Reported	BG0000

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Non-Inferiority Type
OG001	mean difference vs Placebo	Mixed Models Analysis	>0.5	Mean Difference (Final Values)	3.6	2-Sided	Superiority
OG002	mean difference vs Placebo	Mixed Models Analysis	>0.5	Mean Difference (Net)	-2	2-Sided	Superiority
OG003	mean difference vs Placebo	Mixed Models Analysis	>0.5	Mean Difference (Net)	-6.8	2-Sided	Superiority
OG004	mean difference vs Placebo	Mixed Models Analysis	0.33	Mean Difference (Net)	-11.7	2-Sided	Superiority

Secondary

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

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

Posted

Mean

Standard Error

Liters/minute

1 night

ID	Title	Description
OG000	Placebo	Placebo capsule 1 time before bedtime Placebo oral capsule: Placebo capsule before sleep
OG001	LTM1201L	LTM1201L capsule 1 time before bedtime LTM1201L: LTM1201L capsule before sleep
OG002	LTM1201LN	LTM1201LN capsule 1 time before bedtime LTM1201LN: LTM1201LN capsule before sleep
OG003	LTM1201LB	LTM1201LB capsule 1 time before bedtime LTM1201LB: LTM1201LB capsule before sleep
OG004	LTM1201LD	LTM1201LD capsule 1 time before bedtime LTM1201LD: LTM1201LD capsule before sleep

Units	Counts
Participants	OG0006 OG0015 OG0026 OG003

Title

Denominators