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Trial registered on ANZCTR


Trial ID
ACTRN12612000347864
Ethics application status
Not yet submitted
Date submitted
26/03/2012
Date registered
26/03/2012
Date last updated
15/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate the effects of nocturnal
humidification on sleep apnea and sleep quality, in
patients with Primary Sjogren’s Syndrome(pSS)
Scientific title
Randomised placebo controlled cross-over trial of airway humidification, in patients with
pSS(Primary Sjogrens Syndrome) and to study its effect on sleep architecture.
Secondary ID [1] 280210 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Xerostomia(dry mouth) in patients with primary Sjogrens Syndrome(pSS) 286150 0
Condition category
Condition code
Inflammatory and Immune System 286347 286347 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High intensity humidifier machine(AIRVO), which is currently in clinical use, will be used for nocturnal humidification in patients with pSS.The humidifier device gives warmed and humidified air to the participant through a mask.This device will be used overnight, on the study night during sleep.The patient will have a sleep study performed on this night and the subjective quality of sleep will be assessed next day. Following this there will be a washout period of 1 week. After 1 week the cross over trial will be performed.The sleep study and subjective sleep quality will be assessed during the cross-over trial.
Overall, this study involves use of the humidifier device for 1 night , by each participant who is involved in the study.
Intervention code [1] 284543 0
Treatment: Devices
Comparator / control treatment
Look alike machines (with mask) which do not provide high intensity humidification will be used as controls.
Control group
Placebo

Outcomes
Primary outcome [1] 286809 0
Improvement in apnea-hypopnea index as measured by polysomnography
Timepoint [1] 286809 0
At the start of the study, during the treatment with humidifer and during treatment with placebo
Secondary outcome [1] 296713 0
Measurement of subjective ( Visual analogue scale) and objective (polysomnography) sleep quality
Timepoint [1] 296713 0
After initial screening polysomnogram, after treatment with humidifier and after treatment with placebo

Eligibility
Key inclusion criteria
Patients with primary Sjogrens Syndrome (pSS), as per the revised version of the European criteria proposed by the American-European Consensus Group, with an Apnea-hypopnea index (AHI) of >10 events/hour, measured on polysomnogram.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give consent, co-existing sleep disorders like restless leg syndrome,narcolepsy etc, major medical co-morbidities like unstable heart disease, unstable airways disease,uncontrolled diabetes mellitus, patients on chemotherapy

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
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284963 0
Hospital
Name [1] 284963 0
Adelaide Institute for Sleep health
Address [1] 284963 0
Repatriation General Hospital
Daws Road
Daw Park
SA 5041
Country [1] 284963 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] 283835 0
None
Name [1] 283835 0
Address [1] 283835 0
Country [1] 283835 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286971 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286971 0
Southern Adelaide Health Service
Room 2A221 - Inside Human Resources
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 286971 0
Australia
Date submitted for ethics approval [1] 286971 0
19/03/2012
Approval date [1] 286971 0
Ethics approval number [1] 286971 0

Summary
Brief summary
Excessive dryness of mouth and throat, occurs in patients with Sjogrens Syndrome. This could result in sleep disturbance and predispose to obstructive sleep apnea. A previous study has reported that nocturnal humidification (moistening the mouth and throat at night) improved mouth dryness and decreased sleep disturbance. It might be possible therefore to improve sleep apnea and sleep quality in patients with Sjogrens Syndrome by using special mask and device which will deliver humidified air and
keep mouth and throat moistened, during night.Our aim is to find out the usefulness of nocturnal humidification (giving humidified air through a mask during sleep at
night) in improving sleep apnea and sleep quality in patients with Sjogrens Syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33973 0
Address 33973 0
Country 33973 0
Phone 33973 0
Fax 33973 0
Email 33973 0
Contact person for public queries
Name 17220 0
Dr. Vinod Aiyappan
Address 17220 0
Senior Registrar/Sleep Fellow
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park
SA 5041
Country 17220 0
Australia
Phone 17220 0
+61 882751187
Fax 17220 0
+61 882776890
Email 17220 0
vinod.aiyappan@health.sa.gov.au
Contact person for scientific queries
Name 8148 0
Dr. Vinod Aiyappan
Address 8148 0
Senior Registrar/Sleep Fellow
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park
SA 5041
Country 8148 0
Australia
Phone 8148 0
+61 882751187
Fax 8148 0
+61 882776890
Email 8148 0
vinod.aiyappan@health.sa.gov.au