Trial Outcomes & Findings for DAW1033D in Obstructive Sleep Apnea (NCT NCT03383887)

NCT ID: NCT03383887

Last Updated: 2020-02-25

Results Overview

Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 1 night
• Results posted on: 2020-02-25

Participant Flow

Participant milestones

Measure	Placebo First, DAW1033D Second Placebo-matching DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033D administered 30 mins before normal sleep time on second study night.	DAW1033D First, Placebo Second DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Placebo First, DAW1033D Second Placebo-matching DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then DAW1033D administered 30 mins before normal sleep time on second study night.	DAW1033D First, Placebo Second DAW1033D administered 30 mins before normal sleep time on first study night, then a 1-week non-treatment period, then placebo administered 30 mins before normal sleep time on second study night.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

DAW1033D in Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	All Analyzed Participants n=10 Participants All participants who were randomized, completed both study nights, and were included in the analysis.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	5 Participants n=5 Participants
Race (NIH/OMB) White	4 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

Population: 1 participant was not analyzed because he dropped out between the 2 intervention arms

Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.

Outcome measures

Measure	Placebo n=10 Participants Placebo capsule 30 minutes before sleep Placebo oral capsule: Placebo before sleep	DAW1033D n=10 Participants DAW1033D capsule 30 minutes before sleep DAW1033D oral capsule: DAW1033D before sleep
Apnea Hypopnea Index (AHI, Events/Hour of Sleep)	21.6 events/hour of sleep Interval 9.1 to 49.8	37.9 events/hour of sleep Interval 5.1 to 55.4

SECONDARY outcome

Timeframe: 1 night

Ventilation when ventilatory drive is relatively low during sleep

Outcome measures

Measure	Placebo n=10 Participants Placebo capsule 30 minutes before sleep Placebo oral capsule: Placebo before sleep	DAW1033D n=10 Participants DAW1033D capsule 30 minutes before sleep DAW1033D oral capsule: DAW1033D before sleep
Collapsibility of the Upper Airway: VPassive	74.8 % eupneic ventilation Interval 31.5 to 90.8	92.7 % eupneic ventilation Interval 70.0 to 97.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DAW1033D

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=10 participants at risk Placebo capsule 30 minutes before sleep Placebo oral capsule: Placebo before sleep	DAW1033D n=10 participants at risk DAW1033D capsule 30 minutes before sleep DAW1033D oral capsule: DAW1033D before sleep
Nervous system disorders insomnia	0.00% 0/10 • 1 night	10.0% 1/10 • Number of events 1 • 1 night

Additional Information

Luigi Taranto Montemurro, MD

Brigham and Women's Hospital

Phone: 6177326541

Email: ltarantomontemurro@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place