Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000334505
Ethics application status
Approved
Date submitted
5/07/2006
Date registered
8/08/2006
Date last updated
8/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conventional Heated Humidity in Patients Using Continuous Positive Airway Pressure (CPAP)
Scientific title
The effects (on patient utilization and sleep quality) of Conventional Heated Humidity in Patients Using Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea(OSA) on mask on time; sleep parameters; nasal symptoms and quality of life.
Universal Trial Number (UTN)
Trial acronym
TS-HAMAa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 1304 0
Condition category
Condition code
Respiratory 1394 1394 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 weeks of CPAP with ThermoSmart Humidification. Once completed participants will be swapped to the alternate treatment arm. There is no washout between study arms.
Intervention code [1] 1189 0
Treatment: Devices
Comparator / control treatment
4 weeks of CPAP with Conventional Humidification (CH).
Control group
Active

Outcomes
Primary outcome [1] 1899 0
Sleep Quality via Actigraphy - designed to measure rest/activity cycles continuously throughout the 24-hr day. The instrument provides reliable and valid data regarding a number of sleep-related parameters, including Total Sleep Time (TST), awake time spent awake after sleep onset (WASO) and Sleep Efficicney (SE).
Timepoint [1] 1899 0
A 7 day period of actigraphy will be completed in the 7 days leading up to the participants first treatment. For the first week (7 days) of each arm actigraph data will be collected.
Secondary outcome [1] 3360 0
Nocturnal Rhinoconjunctivitis Quality of Life :
Timepoint [1] 3360 0
Assessed at baseline and at the end (after 4 weeks) of each treatment arm.
Secondary outcome [2] 3361 0
Questionnaire (Nocturnal RQLQ)
Timepoint [2] 3361 0
Assessed at baseline and at the end (after 4 weeks) of each treatment arm.
Secondary outcome [3] 3362 0
Epworth Sleepiness Scale
Timepoint [3] 3362 0
Assessed at baseline and at the end (after 4 weeks) of each treatment arm.
Secondary outcome [4] 3363 0
SF-36
Timepoint [4] 3363 0
Assessed at baseline and at the end (after 4 weeks) of each treatment arm.
Secondary outcome [5] 3364 0
Full Polysomnograph will be undertaken.
Timepoint [5] 3364 0
Within 2 weeks prior to commencement of study.

Eligibility
Key inclusion criteria
A previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.AHI = 15 OR AHI = 5 + ESS = 10 OR ESS = 10 + a medical co-morbidityPatient willing to give informed consent and follow study protocol.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Wake resting SpO2 < 90%Patient requires BiLevel PAP or supplemental oxygenThe patient is medically unstable (e.g. respiratory or cardiac failure)Patient unwilling to give informed consent or follow study protocol.AHI: Apnea Hypopnea Index (degree of severity of OSA)ESS: Epworth Sleepiness Scale (degree of daytime sleepiness).

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 375 0
New Zealand
State/province [1] 375 0

Funding & Sponsors
Funding source category [1] 1528 0
Commercial sector/Industry
Name [1] 1528 0
Fisher and Paykel Healthcare
Country [1] 1528 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 1342 0
None
Name [1] 1342 0
NIL
Address [1] 1342 0
Country [1] 1342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2952 0
Alexian Brothers Hospital Network-the suburban lung asscoiates medical centre in Chicago
Ethics committee address [1] 2952 0
Ethics committee country [1] 2952 0
United States of America
Date submitted for ethics approval [1] 2952 0
Approval date [1] 2952 0
06/04/2006
Ethics approval number [1] 2952 0
0655

Summary
Brief summary
Participants will be randomised to 4 weeks of CPAP with Conventional Humidification (CH) or 4 weeks of CPAP with ThermoSmart Humidification. Once completed participants will be swapped to the alternate treatment arm.
Sleep Quality via Actigraphy - designed to measure rest/activity cycles continuously throughout the 24-hr day. The instrument provides reliable and valid data regarding a number of sleep-related parameters, including Total Sleep Time (TST), (awake time spent awake after sleep onset (WASO) and Sleep Efficicney (SE)
A 7 day period of actigraphy will be completed in the 7 days leading up to the participants first treatment.
For the first week (7 days) of each arm actigraph data will be collected. Both trial administrator and subjects will be blinded. the devices are identical looking and neither administrator nor subject will know which is which.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35181 0
Address 35181 0
Country 35181 0
Phone 35181 0
Fax 35181 0
Email 35181 0
Contact person for public queries
Name 10378 0
Georgina Cuttance
Address 10378 0
15 Maurice Paykel Place
East Tamaki
Auckland
Country 10378 0
New Zealand
Phone 10378 0
+64 9 5740123 ext. 8822
Fax 10378 0
Email 10378 0
[email protected]
Contact person for scientific queries
Name 1306 0
Georgina Cuttance
Address 1306 0
15 Maurice Paykel Place
East Tamaki
Auckland
Country 1306 0
New Zealand
Phone 1306 0
+64 9 5740123 ext. 8822
Fax 1306 0
Email 1306 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.