Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000203459
Ethics application status
Approved
Date submitted
18/01/2007
Date registered
13/04/2007
Date last updated
13/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Study of Compliance and Side Effects Under Continuous Positive Airway Pressure with Heated Humidification and Continuous Positive Airway Pressure with Heated Humidification and Additional Tube Heating.
Scientific title
Randomized Controlled Study of the Compliance and Side effects of Continuous Positive Airway Pressure with Heated Humidification Compared to Continuous Positive Airway Pressure with Heated Humidification with Additional Heated Breathing Tube in Patients with Obstructive Sleep Apnea.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 1728 0
Condition category
Condition code
Respiratory 1819 1819 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Treatment group B will receive Continuous Positive Airway Pressure (CPAP) with heated humidification delivered via a heated breathing tube

Dose: Pressure for each patient will be determined via a overnight polysomnography, pressure is increased until there is no longer any sleep disordered breathing or a apnea hypopnea index less than 5. Pressure range will be between 4cmH20 and 20cmH20.

Duration: Subjects will use treatment at a dose prescribed to treat sleep disordered breathing every time the patient sleeps for 12 months. There is no strict number of hours that the patient is required to sleep with the device, patients will use the device at each sleep session for as long as they can tolerate optimally until they awake in the morning. Range of hours will be between 0 and 12 hours usage.
Intervention code [1] 1563 0
Treatment: Devices
Comparator / control treatment
Treatment group A will receive Continuous Positive Airway Pressure (CPAP) with heated humidification
Control group
Active

Outcomes
Primary outcome [1] 2550 0
Compliance
Timepoint [1] 2550 0
At 1, 6 and 12 months
Secondary outcome [1] 4394 0
Quality of life and side effects
Timepoint [1] 4394 0
12 months

Eligibility
Key inclusion criteria
Newly diagnosed sleep apnoea syndrome. Apnea hypopnea index (AHI) > 5/hr, accompanied by clinical symptoms of sleep apnoea. Written consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No consent givenCerebral disordersPeriodic Leg Movement Syndrome (PLMS) during sleepExacerbated chronic obstructive respiratory illnessesDecompensated heart insufficiencyMalignant heart arrhythmia or uncontrolled arterial hypertoniaPregnancyMalignant illnesses.

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 Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator formula in an Excel Spreadsheet
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects are blind in this study
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 473 0
New Zealand
State/province [1] 473 0

Funding & Sponsors
Funding source category [1] 1971 0
Commercial sector/Industry
Name [1] 1971 0
Fisher and Paykel Healthcare Limited
Country [1] 1971 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare Limited
Address
Country
New Zealand
Secondary sponsor category [1] 1783 0
None
Name [1] 1783 0
n/a
Address [1] 1783 0
Country [1] 1783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3666 0
Krankenhaus Bethanien
Ethics committee address [1] 3666 0
Solingen
Ethics committee country [1] 3666 0
Germany
Date submitted for ethics approval [1] 3666 0
Approval date [1] 3666 0
28/03/2007
Ethics approval number [1] 3666 0
03/2007

Summary
Brief summary
Patients will be recruited and randomly assigned to one of two treatment groups.

Treatment group 1 will receive CPAP with a heated humidification
Treatment group B will receive CPAP with heated humidification delivered via a heated breathing tube

Duration: 12 months

Patient compliance, quality of life and side effects of CPAP treatment will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27497 0
Address 27497 0
Country 27497 0
Phone 27497 0
Fax 27497 0
Email 27497 0
Contact person for public queries
Name 10752 0
Jessica Hayward
Address 10752 0
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
Country 10752 0
New Zealand
Phone 10752 0
+64 5740123 ext.7327
Fax 10752 0
+64 5740148
Email 10752 0
[email protected]
Contact person for scientific queries
Name 1680 0
Jessica Hayward
Address 1680 0
Stewart Building
15 Maurice Paykel Place
East Tamaki
Auckland
Country 1680 0
New Zealand
Phone 1680 0
+64 5740123 ext.7327
Fax 1680 0
+64 5740148
Email 1680 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
SourceTitleYear of PublicationDOI
EmbaseEffect of a Heated Breathing Tube on Efficacy, Adherence and Side Effects during Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea.2016https://dx.doi.org/10.1159/000442052
N.B. These documents automatically identified may not have been verified by the study sponsor.