Trial Outcomes & Findings for Pharmacological Activation of HMN for OSA (NCT NCT03640052)

Last Updated: 2020-02-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

1 night

Results posted on

2020-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First Placebo administered before sleep for 1 night, followed by LTM1201L, LTM1201LD, LTM1201LN and LTM1201LB, administered 1 week apart in the hospital	LTM1201L First LTM1201L administered before sleep for 1 night, followed by LTM1201LD, LTM1201LN, LTM1201LB and Placebo, administered 1 week apart in the hospital	LTM1201LD First LTM1201LD administered before sleep for 1 night, followed by LTM1201LN, LTM1201LB, Placebo and LTM1201L, administered 1 week apart in the hospital	LTM1201LN First LTM1201LN administered before sleep for 1 night, followed by LTM1201LB, Placebo, LTM1201L and LTM1201LD administered 1 week apart in the hospital	LTM1201LB First LTM1201LB administered before sleep for 1 night, followed by Placebo, LTM1201L, LTM1201LD and LTM1201LN administered 1 week apart in the hospital
Overall Study STARTED	2	1	1	1	1
Overall Study COMPLETED	2	0	1	1	1
Overall Study NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo First Placebo administered before sleep for 1 night, followed by LTM1201L, LTM1201LD, LTM1201LN and LTM1201LB, administered 1 week apart in the hospital	LTM1201L First LTM1201L administered before sleep for 1 night, followed by LTM1201LD, LTM1201LN, LTM1201LB and Placebo, administered 1 week apart in the hospital	LTM1201LD First LTM1201LD administered before sleep for 1 night, followed by LTM1201LN, LTM1201LB, Placebo and LTM1201L, administered 1 week apart in the hospital	LTM1201LN First LTM1201LN administered before sleep for 1 night, followed by LTM1201LB, Placebo, LTM1201L and LTM1201LD administered 1 week apart in the hospital	LTM1201LB First LTM1201LB administered before sleep for 1 night, followed by Placebo, LTM1201L, LTM1201LD and LTM1201LN administered 1 week apart in the hospital
Overall Study Lost to Follow-up	0	1	0	0	0

Baseline Characteristics

Pharmacological Activation of HMN for OSA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Analyzed Participants n=6 Participants All participants who were randomized, completed both study nights, and were included in the analysis.
Age, Continuous	50.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 night

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Placebo capsule 1 time before bedtime Placebo oral capsule: Placebo capsule before sleep	LTM1201L n=6 Participants LTM1201L capsule 1 time before bedtime LTM1201L: LTM1201L capsule before sleep	LTM1201LN n=6 Participants LTM1201LN capsule 1 time before bedtime LTM1201LN: LTM1201LN capsule before sleep	LTM1201LB n=5 Participants LTM1201LB capsule 1 time before bedtime LTM1201LB: LTM1201LB capsule before sleep	LTM1201LD n=6 Participants LTM1201LD capsule 1 time before bedtime LTM1201LD: LTM1201LD capsule before sleep
Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)	20.8 events/hour of sleep Standard Error 8	24.4 events/hour of sleep Standard Error 11.3	18.8 events/hour of sleep Standard Error 11.3	14 events/hour of sleep Standard Error 11.3	9.1 events/hour of sleep Standard Error 11.9

SECONDARY outcome

Timeframe: 1 night

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