Effects of noradrenergic and antimuscarinic agents on obstructive sleep apnoea (OSA) and upper airway muscle activity during sleep

Effects of noradrenergic and antimuscarinic agents on obstructive sleep apnoea (OSA) severity and upper airway muscle activity during sleep in OSA

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001326381

Enrollment

Registered

2017-09-15

Start date

2017-11-15

Completion date

2019-03-25

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine if a combined noradrenergic/antimuscarinic intervention changes sleep apnoea severity compared to placebo and the effects on pharyngeal muscle activity and other key sleep parameters.

Interventions

Reboxetine 4mg + Hyoscine 20mg taken orally just prior to sleep (single dose), 1 week washout. The study intervention for this acute, single night, in-laboratory, sleep study (polysomnography) to be performed at NeuRA will be administered by the researchers to ensure a adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Otherwise healthy men and women with obstructive sleep apnoea aged 18-65 years

Exclusion criteria

-Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. -Patients with any other medical condition which may interfere in the evaluation of the study. -Patients with a previous history of addiction to alcohol or drugs. -Patients taking medications known to affect sleep or muscle activity.

Outcome results