Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000113853
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
24/01/2012
Date last updated
24/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Surfactant for Obstructive Sleep Apnea in Patients with Primary Sjogren’s Syndrome: A randomised, placebo controlled study.
Scientific title
Surfactant for OSA in Patients with Primary Sjogren’s Syndrome for improvement of AHI and Sicca Symptoms: A randomised, placebo controlled study.
Secondary ID [1] 279755 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea in patients with primary sjogren's syndrome. 285623 0
Condition category
Condition code
Respiratory 285815 285815 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surfactant (abbott's Survanta) 4.0mls topically into upper airways(half the dose via oropharynx and half via nasopharynx). The dose was given at baseline prior to sleep onset and repeated 3.5 hours after sleep onset.

On the consecutive night surfactant will be crossed over by 4.0 mls of 0.9 % normal saline via same route and with same frequency.
Intervention code [1] 284075 0
Treatment: Drugs
Comparator / control treatment
Normal saline 4.o mls which will be crossed over to surfactant 4.0mls on the consecutive night.
Control group
Placebo

Outcomes
Primary outcome [1] 286327 0
Apnea Hypopnea Index (AHI) as measured by overnight sleep study. AHI is computed by dividing the total number of hypopneas (events of reduced flow of braeth) and Apneas (No flow of breath) by the total time asleep in hour.
Timepoint [1] 286327 0
Overnight only- two consecutive nights of cross over-intervention vs placebo
Secondary outcome [1] 295611 0
Sicca Score.
Quality of Sleep
Morning Alertness
Timepoint [1] 295611 0
Overnight only- two consecutive nights of cross over-intervention vs placebo

Eligibility
Key inclusion criteria
Obstructive Sleep Apnea
Primary Sjogren's Syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe gag reflex
Severe cognitive impairment
Not willing to participate

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?



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
18/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284542 0
Charities/Societies/Foundations
Name [1] 284542 0
Foundation Daw Park
Country [1] 284542 0
Australia
Primary sponsor type
Hospital
Name
Adelaide Institute for Sleep Health
Address
Repatriation General Hospital,
Daws Road, Daw Park, SA 5041
Country
Australia
Secondary sponsor category [1] 283470 0
None
Name [1] 283470 0
Address [1] 283470 0
Country [1] 283470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286528 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286528 0
Southern Adelaide Clinical Human Research Ethics Committee

SA Health

Room 2A221 - Inside Human Resources

Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 286528 0
Date submitted for ethics approval [1] 286528 0
Approval date [1] 286528 0
17/03/2011
Ethics approval number [1] 286528 0
1/10/0455

Summary
Brief summary
Our group has recently found that women with primary Sjogren’s syndrome (an autoimmune disease causing dry eyes and mouth) are considerably more likely to suffer obstructive sleep apnoea (OSA) compared to women without Sjogren’s syndrome. OSA is a common condition in which the upper airway repeatedly closes during sleep and can lead to severe daytime sleepiness, one of the common problems reported by Sjogren’s sufferers. A likely key cause of OSA in Sjogren’s syndrome is reduced and stickier airway secretions that may predispose to airway obstruction and disturbed sleep at night. Recent research in OSA patients without Sjogren’s syndrome has shown that lubricating the upper airway with a substance called surfactant improves OSA. Surfactants are naturally produced in the lung and work by decreasing the “stickiness” (surface tension) of fluids. Therefore, at least in OSA patients without Sjogren’s syndrome, surfactants applied to the upper airway appear to help the airway to stay open and reopen more easily if it becomes closed. Women with Sjogren’s syndrome are likely to similarly benefit from this form of treatment.
The aim of this study is to determine whether the topical application of surfactant in women with primary Sjogren’s Syndrome who have obstructive sleep apnoea as well, will reduce the severity of their OSA and salivary stickiness and will improve their symptoms of overnight dryness and general morning well-being or not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33654 0
Address 33654 0
Country 33654 0
Phone 33654 0
Fax 33654 0
Email 33654 0
Contact person for public queries
Name 16901 0
Dr Zafar A Usmani
Address 16901 0
Adelaide Institute for Sleep Health, Repatriation General Hospital, Daws Road, Daw park, SA 5020, Australia.
Country 16901 0
Australia
Phone 16901 0
61882751311
Fax 16901 0
61882751311
Email 16901 0
[email protected]
Contact person for scientific queries
Name 7829 0
Dr Zafar A Usmani
Address 7829 0
Adelaide Institute for Sleep Health,
Repatriation General hospital,
Daws Road, Daw Park,
SA 5041,
Australia
Country 7829 0
Australia
Phone 7829 0
61882751311
Fax 7829 0
61882751311
Email 7829 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
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