Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000572561
Ethics application status
Approved
Date submitted
17/05/2015
Date registered
3/06/2015
Date last updated
3/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of prototype Intranasal Stent & Positive Expiratory Airway Pressure device to treat Moderate Obstructive Sleep Apnoea
Scientific title
Pilot Study of prototype Intranasal Stent & Positive Expiratory Airway Pressure device to treat Moderate Obstructive Sleep Apnoea
Secondary ID [1] 286699 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 295055 0
Condition category
Condition code
Respiratory 295306 295306 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A phase 1, proof of concept pilot series will evaluate the use of Rhinomed's prototype of an intranasal stent and positive expiratory pressure device (RHI-003 NBV001) for moderate obstructive sleep apnoea. This stenting device contains a one way valve that facilitates inspiration unimpeded and delivers an expiratory resistance that creates expiratory positive pressure to the pharynx. 20 subjects are fitted and trained to self insert the device by the researchers. Polysomnography using the device on night 1 will compare sleep apneoa severity to baseline. Two weeks of nightly usage in their own home will be monitored with self reported compliance log and repeat partner assisted snoring analogue scale questionnaire. Subjects will be assigned a device for night 1 to 3 with a non-therapeutic expiratory effect with 2.5mm valve diameter, nights 3 to 6 with 2mm valve diameter and then nights 7-14 with therapeutic expiratory effect with a 1.5mm valve diameter. This will assist with acclimation.
Intervention code [1] 291846 0
Treatment: Devices
Comparator / control treatment
This is a pilot case series without control arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295042 0
To determine the effect of an intranasal expiratory pressure device on moderate obstructive sleep apnoea measured by in laboratory polysomnography
Timepoint [1] 295042 0
Device response is measured by polysomnography on first night of use. Pilot data measuring self reports of nightly usage will be collected for 14 consecutive nights
Secondary outcome [1] 314663 0
Tolerability of an intranasal expiratory pressure device used nightly for 14 trial nights in the domestic environment. This will be determined by a subjective report using 5 point visual analogue scale of comfort and self report of hours of usage per night.
Timepoint [1] 314663 0
After 14 days of home usage during sleep
Secondary outcome [2] 314837 0
Partner assisted self report of subjective snoring severity measured by an analogue scale
Timepoint [2] 314837 0
Data will be collected daily for 14 trial days

Eligibility
Key inclusion criteria
- Moderate obstructive sleep apnoea (apnoea hypopnoea index >15 events per hour and <30 events per hour).

- Witness in the domestic environment to report on snoring severity.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to fit intranasal stent device comfortably
- Unable to provide informed consent
- Major cardiorespiratory comorbidity
- Current treatment for obstructive sleep apnoea

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with a new diagnosis of moderate obstructive sleep apnoea presenting from respiratory and sleep clinics from Monash Health Melbourne may be notified of the trial.

A study coordinator will provide information as to the purpose, design and requirements of the study. All consenting subjects will be enrolled into the intervention arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be performed using student t test for parametric data.

20 subjects will be enrolled aiming for 20% reduction in severity of obstructive sleep apnoea and 90% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3791 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 9672 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 291267 0
Commercial sector/Industry
Name [1] 291267 0
Rhinomed Limited
Country [1] 291267 0
Australia
Primary sponsor type
Hospital
Name
Monash Lung and Sleep
Address
Monash Health 246 Clayton Rd Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 290047 0
Commercial sector/Industry
Name [1] 290047 0
Rhinomed LTD
Address [1] 290047 0
1/1233 High Street Armadale 3143 Victoria
Country [1] 290047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292826 0
MonashHealth Human Research Ethics Committee
Ethics committee address [1] 292826 0
Level 2, I Block Monash Medical Centre
246 Clayton Rd Clayton Victoria 3168
Ethics committee country [1] 292826 0
Australia
Date submitted for ethics approval [1] 292826 0
Approval date [1] 292826 0
22/04/2015
Ethics approval number [1] 292826 0
15040A

Summary
Brief summary
This is a phase 1 proof of concept trial measuring the effect of a novel intranasal stent and tolerability of an expiratory positive pressure device on subjects with moderate obstructive sleep apnoea.
Hypothesis: The combination fo dilation of the nasal cavity with an intranasal stent combined with a valve that increases pressure to the upper airway on expiration will favorably effect moderate sleep apnoea and snoring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57230 0
A/Prof Darren Mansfield
Address 57230 0
Monash Lung and Sleep
Monash Health
246 Clayton Rd
Clayton 3168
Victoria
Country 57230 0
Australia
Phone 57230 0
613 9594 6666
Fax 57230 0
61395946415
Email 57230 0
[email protected]
Contact person for public queries
Name 57231 0
Darren Mansfield
Address 57231 0
Monash Lung and Sleep
Monash Health
246 Clayton Rd
Clayton
Victoria 3168
Country 57231 0
Australia
Phone 57231 0
61395946666
Fax 57231 0
61395946415
Email 57231 0
[email protected]
Contact person for scientific queries
Name 57232 0
Darren Mansfield
Address 57232 0
Monash Lung and Sleep
Monash Health
246 Clayton Rd
Clayton
Victoria 3168
Country 57232 0
Australia
Phone 57232 0
61395946666
Fax 57232 0
61395946415
Email 57232 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.