The effects of nasal decongestion on obstructive sleep apnoea severity in people with tetraplegia

A proof-of-concept study of the effect of nasal phenyepherine versus placebo on the apnoea hypopnoea index in participants with tetraplegia and sleep apnoea

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000229572

Enrollment

Registered

2015-03-12

Start date

2015-02-06

Completion date

2016-07-26

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

The study will trial a common nasal decongestant to determine its effect on OSA severity in people with tetraplegia.

Interventions

Single dose only of 0.5ml of 0.5% nasal phenyepherine spray delivered immediately prior to sleep. Intervention order will be randomised and there will be a one-week washout period between treatments.

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 No maximum

Healthy volunteers

Inclusion criteria

Tetraplegia obstructive sleep apnoea as defined as having an apnoea hypopnoea index of greater than 10 events per hour

Exclusion criteria

Neurologic condition other than tetraplegia Uncontrolled hypertension Significant head injury Ongoing hypercapnic ventilatory failure Allergy to phenylephrine or lignocaine Inability to provide informed consent Fixed nasal obstruction (i.e. nasal fracture or deviated septum) Use of other medication that could influence nasal patency Use of bronchodilators or corticosteroid inhalers

Outcome results