ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001499279

Ethics application status

Approved

Date submitted

3/09/2018

Date registered

6/09/2018

Date last updated

13/09/2022

Date data sharing statement initially provided

21/01/2019

Date results provided

30/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA)

Scientific title

The effects of AD098, AD153 and AD639 on obstructive sleep apnoea (OSA) severity in men and women with moderate-to-severe OSA

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obstructive Sleep Apnoea

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: AD098 - (single dose [one night], combination of drugs [60mg+5mg], oral capsule, administered prior to sleep)
Arm 2: AD153 - (single dose [one night], combination of drugs [50mg+5mg], oral capsule, administered prior to sleep)
Arm 3: AD639 - (single dose [one night], single drug [5mg], oral capsule, administered prior to sleep)
Approximately 1-week washout between each arm

To ensure adherence, all drugs are to be administered by research staff during the in-laboratory sleep studies (polysomnography) performed at the Monash University Sleep Research Facility.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (cellulose capsule) taken orally prior to sleep (participants will act as their own controls in a cross-over design)

Control group

Placebo

Outcomes

Primary outcome [1]

Sleep apnoea severity using the apnoea/hypopnoea index from the overnight polysomnogram

Timepoint [1]

Single acute overnight sleep studies (placebo vs. drug)

Secondary outcome [1]

Subjective sleepiness measured with the Stanford Sleepiness Scale

Timepoint [1]

Single acute overnight sleep studies (placebo vs. drug). 30 mins post-awakening from overnight sleep study

Secondary outcome [2]

Subjective sleep quality will be assessed by asking participants to assign a rating score indicating how they felt they slept during the night of the overnight polysomnogram study (worst:0, best:10)

Timepoint [2]

Single acute overnight sleep studies (placebo vs. drug). 30 mins post-awakening from overnight sleep study

Secondary outcome [3]

Blood pressure (diastolic and systolic) measured with an automatic sphygmomanometer

Timepoint [3]

Single acute overnight sleep studies (placebo vs. drug). Measured 10 minutes before 'lights out' of each overnight sleep study period; and then again at 10 minutes post-awakening in the morning after each night study.

Secondary outcome [4]

Heart rate measured with an automatic sphygmomanometer

Timepoint [4]

Secondary outcome [5]

Sleep efficiency from the overnight polysomnogram

Timepoint [5]

Single acute overnight sleep studies (placebo vs. drug)

Secondary outcome [6]

Hypoxemia from the overnight polysomnogram measured using oximetry

Timepoint [6]

Single acute overnight sleep studies (placebo vs. drug)

Secondary outcome [7]

Arousal index from the overnight polysomnogram

Timepoint [7]

Single acute overnight sleep studies (placebo vs. drug)

Eligibility

Key inclusion criteria

Otherwise healthy men and women with moderate-to-severe obstructive sleep apnoea

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

•Any chronic medical condition other than controlled hypertension, hyperlipidemia, diabetes.
•Any medication known to influence breathing, sleep/arousal or muscle physiology.
•Claustrophobia.
•Inability to sleep supine.
•BMI>45
•Central apnea index >5 events/h
•Tonsillar hypertrophy or craniofacial malformation
•Allergy to lidocaine, oxymetazoline HCl or study medications
•For women: Pregnancy or breast feeding.

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)

Central randomisation by computer

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

Simple randomisation using a randomisation table created by computer software

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 1 / Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Outcomes will be assessed by linear mixed-effect modelling using treatment condition as a fixed effect. Based on a previous pilot study, a sample size of 10 will allow us to detect a difference of 18 (± 18) events/h with 80% power and a 5% level of significance

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/02/2019

Actual

4/02/2019

Date of last participant enrolment

Anticipated

27/05/2019

Actual

25/06/2019

Date of last data collection

Anticipated

26/08/2019

Actual

17/07/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Apnimed

Address [1]

Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Apnimed

Address

Apnimed, Inc.
19 Ware St. Apt. 3
Cambridge, MA 02138
USA

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University Human Research Ethics Committee (MUHREC) 
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/09/2018

Approval date [1]

15/10/2018

Ethics approval number [1]

ID:16795

Summary

Brief summary

The primary aim of this study is to assess the effect that three combinations of drugs (known as AD098, AD153, AD639) have on sleep apnoea severity (i.e. apnoea/hypopnoea index) compared to placebo. Additional measures of sleep apnoea severity, cardiovascular and sleepiness outcomes will also be assessed as secondary outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bradley Edwards

Address

Department of Physiology and School of Psychological Sciences
Faculty of Medicine, Nursing and Health Sciences, Monash University
264 Ferntree Gully Road, Notting Hill,
VIC 3168

Country

Australia

Phone

+613 9905 0187

Fax

bradley.edwards@monash.edu

Contact person for public queries

Name

Bradley Edwards

Address

Department of Physiology and School of Psychological Sciences
Faculty of Medicine, Nursing and Health Sciences, Monash University
264 Ferntree Gully Road, Notting Hill,
VIC 3168

Country

Australia

Phone

+613 9905 0187

Fax

bradley.edwards@monash.edu

Contact person for scientific queries

Name

Bradley Edwards

Address

Department of Physiology and School of Psychological Sciences
Faculty of Medicine, Nursing and Health Sciences, Monash University
264 Ferntree Gully Road, Notting Hill,
VIC 3168

Country

Australia

Phone

+613 9905 0187

Fax

bradley.edwards@monash.edu

Data sharing statement

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

No/undecided IPD sharing reason/comment

This will only be done if participant identity can be assured to remain anonymous in accordance with ethical approval.

What supporting documents are/will be available?

No Supporting Document Provided

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
Dimensions AI	A single dose of noradrenergic/serotonergic reuptake inhibitors combined with an antimuscarinic does not improve obstructive sleep apnoea severity	2022	https://doi.org/10.14814/phy2.15440

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

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Documents added manually

Documents added automatically