ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000469415

Ethics application status

Approved

Date submitted

5/04/2016

Date registered

11/04/2016

Date last updated

17/05/2019

Date data sharing statement initially provided

17/05/2019

Date results provided

17/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Upper airway muscle activity asleep

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (sugar pill), taken orally (participants will act as their own controls in a cross-over design)

Control group

Placebo

Outcomes

Primary outcome [1]

Genioglossus muscle activity during sleep using intramuscular electromyography (EMG).

Timepoint [1]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [1]

Tensor palatini muscle activity during sleep using intramuscular electromyography (EMG).

Timepoint [1]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [2]

Sleep efficiency from the overnight polysomnogram

Timepoint [2]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [3]

Upper airway resistance using an epiglottic pressure catheter

Timepoint [3]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [4]

Minute ventilation measured using a nasal mask and pneumotachograph.

Timepoint [4]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [5]

Arousal index from the overnight polysomnogram

Timepoint [5]

Single night acute overnight sleep studies (placebo vs. drug)

Secondary outcome [6]

Apnoea/hypopnoea index from the overnight polysomnogram

Timepoint [6]

Single night acute overnight sleep studies (placebo vs. drug)

Eligibility

Key inclusion criteria

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

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

14/04/2016

Actual

15/04/2016

Date of last participant enrolment

Anticipated

1/10/2016

Actual

25/07/2016

Date of last data collection

Anticipated

Actual

1/08/2016

Sample size

Target

10

Accrual to date

Final

10

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NeuroSleep (NHMRC Centre of Research Excellence 1060992)

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Neuroscience Research Australia (NeuRA)

Address

Neuroscience Research Australia (NeuRA)
Barker Street,
Randwick, NSW, 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High and Avoca Streets
RANDWICK, NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/08/2015

Approval date [1]

30/11/2015

Ethics approval number [1]

15/234 (HREC/15/POWH/449)

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Danny Eckert

Address

Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031

Country

Australia

Phone

+61 2 9399 1814

Fax

Email

[email protected]

Contact person for public queries

Name

Benjamin Tong

Address

Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031

Country

Australia

Phone

+61 2 9399 1886

Fax

Email

[email protected]

Contact person for scientific queries

Name

Danny Eckert

Address

Neuroscience Research Australia (NeuRA)
PO Box 1165
Randwick, NSW, 2031

Country

Australia

Phone

+61 2 9399 1814

Fax

Email

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De identified individual upper airway muscle data during sleep is provided in the publication.

When will data be available (start and end dates)?

Now (No end date determined).

Available to whom?

Anyone who has access to the publication.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

These individual data are provided within the publication.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2105	Ethical approval					370281-(Uploaded-15-05-2019-12-24-30)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Reboxetine and hyoscine butylbromide improve upper airway function during nonrapid eye movement and suppress rapid eye movement sleep in healthy individuals.	2019	https://dx.doi.org/10.1093/sleep/zsy261

N.B. These documents automatically identified may not have been verified by the study sponsor.