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

NCT05550246 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2022P001544
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI)

  Apneas and hypopneas per hour (3% desat and/or arousal), % change from baseline

  3 days

Secondary Outcomes (2)

• Hypoxic Burden

  3 days

• Arousal Index

  3 days

Study Arms (2)

AtoOxy Predicted Responders

EXPERIMENTAL

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

Drug: Atomoxetine; Drug: Oxybutynin

AtoOxy Predicted Nonresponders

EXPERIMENTAL

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

Drug: Atomoxetine; Drug: Oxybutynin

Interventions

Atomoxetine DRUG

Treatment given for 3 nights

AtoOxy Predicted Nonresponders; AtoOxy Predicted Responders

Oxybutynin DRUG

Treatment given for 3 nights

AtoOxy Predicted Nonresponders; AtoOxy Predicted Responders

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02141, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Atomoxetine Hydrochloride; oxybutynin

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Scott A Sands, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott A Sands, PhD

CONTACT

617-278-0911; sasands@bwh.harvard.edu

Laura K Gell, PhD

CONTACT

617-525-9086; lgell@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants and outcome assessors will be blinded to physiological predicted responder status
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: May 5, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately after publication. No end date.
• Access Criteria: 1-page proposals should be directed to Dr. Scott Sands (sasands@bwh.harvard.edu). To gain access, requestors will be asked to sign a data use agreement.

Locations

US (1)