Sleep ApneaPhase 2NCT03919955

A Novel Pharmacological Therapy for Obstructive Sleep Apnea

A Phase 2 study testing Atomoxetine and Oxybutynin in people with Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Sleep Apnea
What is being tested?: Atomoxetine and Oxybutynin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 117 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2019to 7 Sep 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ages 21-70 years
Diagnosed OSA or clinically-suspected OSA
Not using CPAP (>1 month).

Who cannot join

Any uncontrolled medical condition
Current use of the medications under investigation
Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines).
Current use of SNRIs/SSRIs or anticholinergic medications.
Conditions likely to affect obstructive sleep apnea physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.

Show all 34Show fewer

Respiratory disorders other than sleep disordered breathing:
chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
Contraindications for atomoxetine and oxybutynin, including:
hypersensitivity to study drugs (angioedema or urticaria)
pheochromocytoma
use of monoamine oxidase inhibitors
benign prostatic hypertrophy, urinary retention
untreated narrow angle glaucoma
bipolar disorder, mania, psychosis
history of major depressive disorder (age<24).
history of attempted suicide or suicidal ideation within one year prior to screening
clinically significant constipation, gastric retention
pre-existing seizure disorders
clinically-significant kidney disorders (eGFR<60 ml/min/1.73m2)
clinically-significant liver disorders
clinically-significant cardiovascular conditions
severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline)
cardiomyopathy (LVEF<50%) or heart failure
advanced atherosclerosis
history of cerebrovascular events
history of cardiac arrhythmias e.g., atrial fibrillation, QT prolongation
other serious cardiac conditions that would raise the consequences of an increase in blood pressure or heart rate
myasthenia gravis
pregnancy/breast-feeding
Allergy to lidocaine (Aim 2 only)
Claustrophobia
Pregnancy or nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and oxybutynin, "AtoOxy") over a 1 month period of time. The current study will answer the following questions: Does ongoing, repeated-dose administration of atomoxetine-plus-oxybutynin (referred to as "AtoOxy") improve OSA severity, and do patients exhibit signs of symptomatic relief? Most importantly, which phenotypic subgroup of patients preferentially benefit from this intervention?

Read the detailed description

Aim 1 - Effect of AtoOxy on sleep apnea severity. In a randomized controlled double-blind crossover study, 48 patients with moderate-to-severe OSA will take atomoxetine-plus-oxybutynin ("AtoOxy") versus placebo nightly for 1 month, with a 2-week washout in between. The investigators will test the hypothesis that AtoOxy reduces the Apnea-hypopnea index (primary outcome measure), and improves the following secondary outcomes:

Nocturnal oxygenation, per "hypoxic burden of sleep apnea"
Frequency of arousals from sleep (Arousal index)
Self-reported sleepiness (Epworth Sleepiness Scale)
Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire, Short Form).
Disease-specific quality of life (Sleep Apnea Quality of Life Index, Short Form)

Additional pre-specified exploratory outcome measures will be assessed, including Visual Analog Scales (Sleep Quality, Treatment Satisfaction) and additional polysomnographic measures of sleep (Stage 1 sleep, %total sleep time). Adherence and adverse events will also be carefully monitored to assess repeated-dose tolerance of the intervention.

Aim 2 - Determine which patient phenotypes respond best to AtoOxy. Patients will also take part in an additional night before initiating study medication to measure the key mechanisms causing OSA. The investigators will prospectively test the hypothesis that greater pharyngeal collapsibility determines a reduced response to therapy. They will also separately test the hypotheses that a reduced muscle responsiveness, reduced baseline muscle activation, a higher arousal threshold, and a lower loop gain will facilitate a greater response to therapy.

Conditions: Sleep Apnea
Being tested: Atomoxetine, Oxybutynin, Placebo
Medical subject headings: Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtomoxetineDrug
Also called Strattera
Atomoxetine 80 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.
OxybutyninDrug
Also called Ditropan
Oxybutynin 5 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.
PlaceboDrug
Placebo, per mouth, before bed.Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.

Study groups in NCT03919955
Study group	Role	What they receive
Sequence A: Atomoxetine and Oxybutynin, then Placebo	Experimental	Sequence A: Atomoxetine and Oxybutynin, then Placebo Receives: Drug: Atomoxetine; Drug: Oxybutynin; Drug: Placebo
Sequence B: Placebo, then Atomoxetine and Oxybutynin	Experimental	Sequence B: Placebo, then Atomoxetine and Oxybutynin. Receives: Drug: Atomoxetine; Drug: Oxybutynin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Apnea-hypopnea Index [AHI]
Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline
Measured: one month

Secondary outcomes (5)

Hypoxic Burden
Desaturation area under curve × event frequency, % change from baseline
Measured: one month
Arousal Index
Scored EEG arousals per hour (>3 s), % change from baseline
Measured: one month
Epworth Sleepiness Scale
Self-reported sleepiness on scale of 0-24, higher values indicated greater sleepiness
Measured: one month
Functional Outcomes of Sleep Questionnaire, Short Form
Disease-specific daytime function on scale of 5-20, higher values indicate greater function and quality of life
Measured: one month
Sleep Apnea Quality of Life Index, Short Form
Disease-specific quality of life on scale of 1-7, higher values indicate greater sleep-apnea related quality of life
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 20197 Sep 2023

First posted18 Apr 2019
Study start3 Sep 2019
Primary completion7 Sep 2023
Study completion7 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03919955
Sponsor's protocol ID: 2019P000666
Other IDs: R01HL146697
Status last verified: Jun 2026
First submitted: 16 Apr 2019
Last updated: 2 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All IPD collected during the study, after deidentification, will be available 12 months after publication to researchers who provide a methodologically sound proposal for any purpose.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Novel Pharmacological Therapy for Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03919955
Acronym / sponsor ID: 2019P000666
Conditions: Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 3 Sep 2019 (actual)
Primary completion: 7 Sep 2023 (actual)
Study completion: 7 Sep 2023 (actual)
First posted: 18 Apr 2019 (actual)
Results: Posted 23 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Nocturnal oxygenation, per "hypoxic burden of sleep apnea"
Frequency of arousals from sleep (Arousal index)
Self-reported sleepiness (Epworth Sleepiness Scale)
Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire, Short Form).
Disease-specific quality of life (Sleep Apnea Quality of Life Index, Short Form)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sequence A: Atomoxetine and Oxybutynin, then Placebo	Experimental	Drug: Atomoxetine, Drug: Oxybutynin, Drug: PlaceboSequence A: Atomoxetine and Oxybutynin, then Placebo
Sequence B: Placebo, then Atomoxetine and Oxybutynin	Experimental	Drug: Atomoxetine, Drug: Oxybutynin, Drug: PlaceboSequence B: Placebo, then Atomoxetine and Oxybutynin.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ages 21-70 years
Diagnosed OSA or clinically-suspected OSA
Not using CPAP (>1 month).

Key exclusion criteria (34 listed)

Any uncontrolled medical condition
Current use of the medications under investigation
Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
Current use of hypnotic medications (trazodone, eszopiclone, benzodiazepines).
Current use of SNRIs/SSRIs or anticholinergic medications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AtomoxetineAlso: StratteraAtomoxetine 80 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.	Drug	Sequence A: Atomoxetine and Oxybutynin, then Placebo, Sequence B: Placebo, then Atomoxetine and Oxybutynin
OxybutyninAlso: DitropanOxybutynin 5 mg, per mouth, before bed. Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.	Drug	Sequence A: Atomoxetine and Oxybutynin, then Placebo, Sequence B: Placebo, then Atomoxetine and Oxybutynin
PlaceboPlacebo, per mouth, before bed.Participants will take the intervention nightly for one month. Half doses will be given on the first three nights.	Drug	Sequence A: Atomoxetine and Oxybutynin, then Placebo, Sequence B: Placebo, then Atomoxetine and Oxybutynin

Primary outcome

Apnea-hypopnea Index [AHI]
Time frame: one month
Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline

5 secondary outcomes

Hypoxic Burden
Time frame: one month
Arousal Index
Time frame: one month
Epworth Sleepiness Scale
Time frame: one month
Functional Outcomes of Sleep Questionnaire, Short Form
Time frame: one month
Sleep Apnea Quality of Life Index, Short Form
Time frame: one month

Results and safety

Results posted to the registry on 23 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence AB	29	26
Sequence BA	29	24

Primary outcome: Apnea-hypopnea Index [AHI]

Time frame: one month. Median (Inter-Quartile Range). Unit: events/hr; % change from baseline

Measure	Active Intervention n = 50	Placebo Intervention n = 53
Value	-11.8 (-44.9 to 7.2)	-2.3 (-29.3 to 17.6)

Population analysed: Population reported here is the population who completed a given treatment period. (Rather, formal statistical analysis was performed using multiple imputation.)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: One month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Intervention	1 of 55 (1.8%)	39 of 55 (70.9%)	0 of 55
Placebo Intervention	0 of 55 (0%)	20 of 55 (36.4%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All IPD collected during the study, after deidentification, will be available 12 months after publication to researchers who provide a methodologically sound proposal for any purpose.

Related trials for Sleep Apnea

RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott A Sands, PhD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atomoxetine and Oxybutynin in people with Sleep Apnea, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-hypopnea Index [AHI] (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03919955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.