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Effects of Female Sex Hormones over the Course of the Menstrual Cycle on Optimal CPAP Pressures Used in the Treatment of Obstructive Sleep Apnoea

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12606000461594
Enrollment
20
Registered
2006-11-03
Start date
2006-12-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Institute for Breathing and Sleep
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Pre-menopausal.

Exclusion criteria

Other sleep disorderMenstrual cycle disorderTreatment with oral hormone replacementSevere medical, psychological or psychiatric co-morbidities.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026