RECRUITING

Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Identifying Sleep Apnea Patients That Best Respond to Atomoxetine Plus Oxybutynin Therapy

Quick Facts

Study Start:2022-05-05

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05550246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Scott A Sands, PhD

CONTACT

617-278-0911

sasands@bwh.harvard.edu

Laura K Gell, PhD

CONTACT

617-525-9086

lgell@bwh.harvard.edu

Principal Investigator

Scott A Sands, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02141

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Scott A Sands, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-05

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-05-05

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea