Effects of noradrenergic and antimuscarinic agents on upper airway muscle activity during sleep

Effects of noradrenergic and antimuscarinic agents on upper airway muscle activity during sleep in healthy adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000469415

Enrollment

Registered

2016-04-11

Start date

2016-04-15

Completion date

2016-07-25

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To determine if sleep-related reductions in upper airway muscle activity during sleep will be higher after a combined noradrenergic/antimuscarinic intervention compared to placebo.

Interventions

Reboxetine 4mg + Hyoscine 20mg taken orally just prior to sleep (single dose) 1 week washout

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

Yes

Inclusion criteria

Healthy men and women aged 18-65 years who do not have any known sleep disorders

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