Recruiting
Phase 1
Phase 2

Atomoxetine Plus Oxybutynin

Sponsor:

Brigham and Women's Hospital

Code:

NCT05550246

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Atomoxetine

Oxybutynin

Study Details

Brief summary:

Atomoxetine-plus-oxybutynin therapy (AtoOxy) has been shown to substantially reduce obstructive sleep apnea severity (OSA) in about half of patients. Here, the investigators will study which patients respond meaningfully to therapy using pathophysiological traits measured at baseline sleep studies.

Conditions

Obstructive Sleep Apnea

Study ID

NCT05550246

Start date

May 5, 2022

Status verified date

Oct, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Suspected or diagnosed OSA
  • Recent drug induced sleep endoscopy results available (performed as part of routine clinical care).

Exclusion Criteria:

  • 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.
  • 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, narcolepsy, or parasomnias.
  • Contraindications for atomoxetine and oxybutynin, including:

  • hypersensitivity to atomoxetine or oxybutynin (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
  • moderate-to-severe hypertension (SBP>180 mmHg or DBP>110 mmHg measured at baseline; average of evening and morning measures\*)
  • 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
  • Claustrophobia
  • Pregnancy or nursing

n.b. Development of new hypertension that is recognized on the final day of study medications during outcomes collection will not be used as stopping criteria for discontinuing outcomes collection.

Participants that are sexually active and able to become pregnant must agree to use birth control for the entire study.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AtoOxy Predicted Responders

Participants will take Atomoxetine (80mg) and Oxybutynin (5mg) before bedtime for 3 nights. Half doses will be given on the first night.

experimental: AtoOxy Predicted Nonresponders

Participants will take Atomoxetine (80mg) and Oxybutynin (5mg) before bedtime for 3 nights. Half doses will be given on the first night.

Interventions

Atomoxetine

Treatment given for 3 nights

Oxybutynin

Treatment given for 3 nights

Primary outcome measure

  • Apnea-hypopnea index (AHI) [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02141

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 18, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-10-18.