Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000461594
Ethics application status
Not yet submitted
Date submitted
1/11/2006
Date registered
3/11/2006
Date last updated
3/11/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Female Sex Hormones over the Course of the Menstrual Cycle on Optimal CPAP Pressures Used in the Treatment of Obstructive Sleep Apnoea
Scientific title
Effects of Female Sex Hormones over the Course of the Menstrual Cycle on Optimal Continuous Positive Airway Pressure (CPAP) Pressures Used in the Treatment of Obstructive Sleep Apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1436 0
Condition category
Condition code
Respiratory 1533 1533 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Continuous Positive Airway Pressure (CPAP) over 5 weeks at home. The patients will be experienced CPAP users and will also be reviewed on mask fit and knowledge of how use the CPAP machine prior to commencing the study. Positive air pressure is applied to the upper airway via a mask, respiratory tubing and CPAP machine interface to splint the pharynx during sleep every night for 5 weeks. The CPAP machine continuously records CPAP pressure levels, air leak, and respiratory events throughout each night. This recorded data will be downloaded onto a desktop computer at the end of the study period. The menstrual cycle will be followed using body temperature measurements (digital oral measurements) measured by the patients each morning at home immediately on arousal from sleep, and a weekly intravenous blood sample will be taken from the patients for competitive binding immunoassays of plasma progesterone and oestradiol levels.
Intervention code [1] 1427 0
Treatment: Devices
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2116 0
Observing any changes in CPAP pressure requirement over five weeks (one menstrual cycle). Estimated that this will occur during the early Luteal phase of the menstrual cycle. The Luteal phase is defined as the period of time following the mid-cycle surge in Luteinising Hormone, and is associated with ovulation. The Luteal phase ends at the beginning of the following menses (menstrual period).
Timepoint [1] 2116 0
Over five weeks (one menstrual cycle).
Secondary outcome [1] 3659 0
Patients will be required to note any changes in their normal daily activities as well as medication and alcohol or caffeine intake, in a daily journal supplied by the investigators for 5 weeks, to evaluate if there are any confounding factors that would affect airway patency, sleep quality or core body temperature.
Timepoint [1] 3659 0

Eligibility
Key inclusion criteria
Pre-menopausal.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Other sleep disorderMenstrual cycle disorderTreatment with oral hormone replacementSevere medical, psychological or psychiatric co-morbidities.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1671 0
Other
Name [1] 1671 0
Institute for Breathing and Sleep
Country [1] 1671 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Country
Australia
Secondary sponsor category [1] 1474 0
None
Name [1] 1474 0
Nil
Address [1] 1474 0
Country [1] 1474 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3114 0
Austin Health Human Research Ethics Committee.
Ethics committee address [1] 3114 0
Ethics committee country [1] 3114 0
Australia
Date submitted for ethics approval [1] 3114 0
Approval date [1] 3114 0
Ethics approval number [1] 3114 0
Ethics committee name [2] 3115 0
Hunter-New England Area Health Service Human Research Ethics Committee
Ethics committee address [2] 3115 0
Ethics committee country [2] 3115 0
Australia
Date submitted for ethics approval [2] 3115 0
Approval date [2] 3115 0
Ethics approval number [2] 3115 0
Ethics committee name [3] 3116 0
University of New England Human Research Ethics Committee
Ethics committee address [3] 3116 0
Ethics committee country [3] 3116 0
Australia
Date submitted for ethics approval [3] 3116 0
Approval date [3] 3116 0
Ethics approval number [3] 3116 0

Summary
Brief summary
There is evidence to suggest that female sex hormone changes (primarily progesterone), during the luteal phase of the menstrual cycle, have protective effects against airway collapse in obstructive sleep apnoea (OSA), thus maintaining airway patency and preventing occlusion. In premenopausal women, who have a cyclical pattern of hormone concentrations over the menstrual cycle, OSA appears to be milder, suggesting that OSA is underdiagnosed in this population sub-group. The treatment of choice for OSA by most sleep physicians is continuous positive airway pressure (CPAP), in which positive air pressure is applied to the upper airway via a mask to splint the pharynx during sleep. To date there appears to be no investigations into the effects of female sex hormones on CPAP pressures as a result of menstrual cycle stage. This study aims to determine whether there is a significant change in the optimal CPAP pressures delivered by an autotitrating CPAP machine over the course of the menstrual cycle in relation to changes in female sex hormones progesterone and oestradiol. For the purposes of this study, optimal pressure is defined as the pressure which is 95% of the maximum pressure delivered by an autotitrating CPAP machine over the sleep period (Pmax 95). Patients will be provided with a ResMed AutoSet (Ryde, Australia) CPAP machine for a period of 5 weeks. Each CPAP machine is capable of continuously recording CPAP pressure levels, air leak, and respiratory events throughout each night. This recorded data will be downloaded onto a desktop computer at the end of the study period. The menstrual cycle will be followed using body temperature measurements (digital oral measurements) measured by the patients each morning at home immediately on arousal from sleep, and a weekly intravenous blood sample will be taken from the patients for competitive binding immunoassays of plasma progesterone and oestradiol levels. Patients will be required to note any changes in their normal daily activities as well as medication and alcohol or caffeine intake, in a daily journal supplied by the investigators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27361 0
Address 27361 0
Country 27361 0
Phone 27361 0
Fax 27361 0
Email 27361 0
Contact person for public queries
Name 10616 0
Dr Maree Barnes
Address 10616 0
Institute for Breathing and Sleep
Austin Health
Studley Road
Heidelberg VIC
Country 10616 0
Australia
Phone 10616 0
+61 3 94965756
Fax 10616 0
Email 10616 0
[email protected]
Contact person for scientific queries
Name 1544 0
Colette Navin
Address 1544 0
Institute for Breathing and Sleep
Austin Health
Studley Road
Heidelberg VIC
Country 1544 0
Australia
Phone 1544 0
+61 3 94963688
Fax 1544 0
Email 1544 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.