Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000288527
Ethics application status
Approved
Date submitted
28/06/2006
Date registered
7/07/2006
Date last updated
7/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect on sleep quality of two levels of heated humidification (during nasal Continuous Positive Airway Pressure therapy) on sleep quality. TS-NILIa
Scientific title
The effect of two levels of heated humidification (during nasal Continuous Positive Airway Pressure therapy for Patients with Obstructive Sleep Apnea) on sleep quality. TS-NILIa
Universal Trial Number (UTN)
Trial acronym
TS-NILIa
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 1263 0
Condition category
Condition code
Respiratory 1349 1349 0 0
Sleep apnoea

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

CPAP + (optimal level of humidity)

STAGE 1:
Participants will be randomised to 2 nights of full sleep study. (one night on each of the study arms)

Outcome measures:
Sleep quality (measured once after each nightime study)


STAGE 2:
After completion of stage 1 of the study particpants will be re-randomised to one of the two study arrms for three weeks at home on this arm. After completion of this 3 weeks particpants will be swapped to the alternate arm.


Outcome measures:
Compliance (recorded at the end of each 3-week arm)
Subjective symptom score; relating to comfort (recorded at the end of each 3-week arm)
Intervention code [1] 1173 0
Treatment: Devices
Comparator / control treatment
CPAP + (conventional heated humidification)
Control group
Active

Outcomes
Primary outcome [1] 1839 0
Sleep Quality
Timepoint [1] 1839 0
Measured during each overnight study (i.e. twice per study subject)
Secondary outcome [1] 3224 0
Subjective symptom score relating to comfort
Timepoint [1] 3224 0
Secondary outcome [2] 3225 0
Compliance
Timepoint [2] 3225 0
Recorded at the end of each three week arm.

Eligibility
Key inclusion criteria
Newly diagnosed obstructive sleep apnea > 10 AHI.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Therapy intolerance determined in the PSG-CPAP titration studyVentilatory insufficiencyMalignant herat rythmn Pregnancy.

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] 369 0
New Zealand
State/province [1] 369 0

Funding & Sponsors
Funding source category [1] 1477 0
Hospital
Name [1] 1477 0
hospital- Klinik Ambrock
Country [1] 1477 0
Funding source category [2] 1478 0
Hospital
Name [2] 1478 0
Klinik fur Pneumologie
Country [2] 1478 0
Funding source category [3] 1479 0
University
Name [3] 1479 0
Universitat Witten-Herdecke, Hagen
Country [3] 1479 0
Primary sponsor type
Hospital
Name
self funded by hospital -Klinik Ambrock, Klinik fur Pneumologie, Universitat Witten-Herdecke, Hagen.
Address
Country
Germany
Secondary sponsor category [1] 1303 0
Commercial sector/Industry
Name [1] 1303 0
Fisher and Paykel Healthcare
Address [1] 1303 0
Country [1] 1303 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2858 0
Klinik Ambrock, Klinik fur Pneumologie, Universitat Witten-Herdecke- the ethical commission of the university Witten/Herdecke
Ethics committee address [1] 2858 0
Ethics committee country [1] 2858 0
Germany
Date submitted for ethics approval [1] 2858 0
Approval date [1] 2858 0
26/04/2006
Ethics approval number [1] 2858 0
26/2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35624 0
Address 35624 0
Country 35624 0
Phone 35624 0
Fax 35624 0
Email 35624 0
Contact person for public queries
Name 10362 0
Georgina Cuttance
Address 10362 0
15 Maurice Paykel Place
East Tamaki
Auckland
Country 10362 0
New Zealand
Phone 10362 0
+64 9 5740123 ext. 8822
Fax 10362 0
Email 10362 0
[email protected]
Contact person for scientific queries
Name 1290 0
Georgina Cuttance
Address 1290 0
15 Maurice Paykel Place
East Tamaki
Auckland
Country 1290 0
New Zealand
Phone 1290 0
+64 9 5740123 ext. 8822
Fax 1290 0
Email 1290 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.