Trial · NCT03919955

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

NCT03919955, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2025-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Novel Pharmacological Therapy for Obstructive Sleep Apnea. Trials, record NCT03919955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03919955

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Novel Pharmacological Therapy for Obstructive Sleep Apnea
NCT number: NCT03919955
Status: Completed
Phases: Phase 2
Enrollment: 117 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Sleep Apnea
Interventions: Atomoxetine, Oxybutynin, Placebo
First posted: 2019-04-18
Last updated: 2026-07-02
Results first posted: 2025-12-23

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apnea-hypopnea Index [AHI]	one month	Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline
Secondary	Hypoxic Burden	one month	Desaturation area under curve × event frequency, % change from baseline
Secondary	Arousal Index	one month	Scored EEG arousals per hour (\>3 s), % change from baseline
Secondary	Epworth Sleepiness Scale	one month	Self-reported sleepiness on scale of 0-24, higher values indicated greater sleepiness
Secondary	Functional Outcomes of Sleep Questionnaire, Short Form	one month	Disease-specific daytime function on scale of 5-20, higher values indicate greater function and quality of life
Secondary	Sleep Apnea Quality of Life Index, Short Form	one month	Disease-specific quality of life on scale of 1-7, higher values indicate greater sleep-apnea related quality of life

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Apnea-hypopnea Index [AHI]	one month	Population reported here is the population who completed a given treatment period. (Rather, formal statistical analysis was performed using multiple imputation.)	events/hr; % change from baseline	MEDIAN
SECONDARY	Hypoxic Burden	one month	secondary outcomes are presented as per primary outcome	%.min/hr; % change from baseline	MEDIAN
SECONDARY	Arousal Index	one month		events/hr; % change from baseline	MEDIAN
SECONDARY	Epworth Sleepiness Scale	one month	All participants who completed questionnaires on treatment.	units on a scale; change from baseline	MEDIAN
SECONDARY	Functional Outcomes of Sleep Questionnaire, Short Form	one month		units on a scale; change from baseline	MEDIAN
SECONDARY	Sleep Apnea Quality of Life Index, Short Form	one month		units on a scale; change from baseline	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Apnea-hypopnea Index [AHI]	Active Intervention	-11.8	Inter-Quartile Range -44.9 to 7.2	events/hr; % change from baseline
Apnea-hypopnea Index [AHI]	Placebo Intervention	-2.3	Inter-Quartile Range -29.3 to 17.6	events/hr; % change from baseline
Hypoxic Burden	Active Intervention	-15.0	Inter-Quartile Range -46.9 to 22.3	%.min/hr; % change from baseline
Hypoxic Burden	Placebo Intervention	-8.7	Inter-Quartile Range -26.9 to 19.9	%.min/hr; % change from baseline
Arousal Index	Active Intervention	-0.3	Inter-Quartile Range -23.9 to 41.5	events/hr; % change from baseline
Arousal Index	Placebo Intervention	-3.7	Inter-Quartile Range -26.2 to 22.2	events/hr; % change from baseline
Epworth Sleepiness Scale	Active Intervention	0	Inter-Quartile Range -3 to 2	units on a scale; change from baseline
Epworth Sleepiness Scale	Placebo Intervention	-1	Inter-Quartile Range -3 to 2	units on a scale; change from baseline
Functional Outcomes of Sleep Questionnaire, Short Form	Active Intervention	0.33	Inter-Quartile Range -1.0 to 1.5	units on a scale; change from baseline
Functional Outcomes of Sleep Questionnaire, Short Form	Placebo Intervention	0	Inter-Quartile Range -1.0 to 2.0	units on a scale; change from baseline

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sequence AB	29
Overall Study	STARTED	Sequence BA	29
Overall Study	Completed Treatment Period 1	Sequence AB	26
Overall Study	Completed Treatment Period 1	Sequence BA	27
Overall Study	Started Treatment Period 2	Sequence AB	26
Overall Study	Started Treatment Period 2	Sequence BA	26
Overall Study	COMPLETED	Sequence AB	26
Overall Study	COMPLETED	Sequence BA	24
Overall Study	NOT COMPLETED	Sequence AB	3
Overall Study	NOT COMPLETED	Sequence BA	5

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dry mouth	Gastrointestinal disorders	Active Intervention	27	55
other	Dry mouth	Gastrointestinal disorders	Placebo Intervention	11	55
other	Drowsiness/Fatigue	General disorders	Active Intervention	13	55
other	Drowsiness/Fatigue	General disorders	Placebo Intervention	8	55
other	Insomnia	General disorders	Active Intervention	13	55
other	Insomnia	General disorders	Placebo Intervention	2	55
other	Decreased appetite	Gastrointestinal disorders	Active Intervention	8	55
other	Decreased appetite	Gastrointestinal disorders	Placebo Intervention	1	55
other	Restlessness	General disorders	Active Intervention	8	55
other	Restlessness	General disorders	Placebo Intervention	1	55

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Intervention	0	55
Total, all-cause mortality	Placebo Intervention	0	55
Total, other adverse events	Active Intervention	39	55
Total, other adverse events	Placebo Intervention	20	55
Total, serious adverse events	Active Intervention	1	55
Total, serious adverse events	Placebo Intervention	0	55

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL146697	A Novel Pharmacological Therapy for Obstructive Sleep Apnea	SANDS, SCOTT A	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2019 to 2023

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active Intervention vs Placebo Intervention: deaths from any cause	Trial comparisons
Active Intervention vs Placebo Intervention: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03919955

GET https://conductscience.org/api/trials/v1/NCT03919955/events?page=2

API reference For AI assistants