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
Alfred-Herrhausen-Str. 50 D58448 Witten
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
The primary purpose of the study is to ascertain if delivering higher levels of humidity to patients undergoing CPAP treatment for Obstructive Sleep Apnea will result in greater comfort; better sleep quality and increased compliance with treatment. Our hypothesis is that supports this theory.

There are two STUDY ARMS:
CPAP + (conventional heated humidification)
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)
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
Georgina.cuttance@fphcare.co.nz
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
Georgina.cuttance@fphcare.co.nz

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.