Trial of combination drug therapy to treat sleep apnoea

Phase 2

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12621000158864
• Lead Sponsor: Flinders University

Brief Summary

In light of observations that histaminergic receptors are highly expressed at the hypoglossal level in the brain and that antimuscarinics increase pharyngeal muscle tone in rapid eye movement (REM) sleep, we tested the combination of betahistine (Beta), to increase histamine levels, with the antimuscarinic oxybutynin (Oxy) on obstructive sleep apnoea (OSA) severity and mechanisms (endotypes). Beta-Oxy increased the sensitivity of the respiratory control system (loop gain) in the absence of an effect on OSA severity, which makes this combination unsuitable for most OSA patients, but may be promising for disorders characterised by reduced chemosensitivity.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-16
• Study Completion: 2021-06-11
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Otherwise healthy adults with obstructive sleep apnoea aged 18 - 75 years with BMI < 40.0kg/m^2 at screening.

Exclusion Criteria

•Any acute or chronic medical condition other than well controlled hypertension , hyperlipidemia, compensated diabetes.
•Any medication known to influence breathing, sleep/arousal or muscle physiology.
•Any medication known to interact with mono amino oxidases.
•Inability to sleep supine (data collection requires a majority of supine position and body position is controlled)
•Any other condition which in the opinion of the investigator would present an unreasonable risk to the participant, or which would interfere with their participation in the study or unduly confound study interpretation, or would render the participant unable or unlikely to understand or comply with the study design, or the receive the specified medications.
•Allergy to oxymetazoline HCl, betahistine dihydrochloride, oxybutynin hydrochloride.
•Bronchial asthma and atopic family history, which are more susceptible to associate with bronchospasm following betahistine dihydrochloride administration.
•Gastric or peptic ulcer, which might be worsened by betahistine dihydrochloride administration on an empty stomach.
•Benign prostatic hyperplasia or urinary retention, which can be exacerbated by the antimuscarinic agent.
•Individuals with underlying cardiac disease, such as arrhythmias.
•Individuals with previous or recent history of phaeochromocytoma.
•Individuals taking tricyclic antidepressants.
•History of moderate or severe renal impairment.
•Pregnancy or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified