Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities

Sponsor

Turku University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01472315

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to evaluate the degree and duration of medroxyprogesterone acetate effect as well as tolerability in postmenopausal women with nasal continuous positive airway pressure (CPAP) treated sleep apnea and to compare the effects with nasal CPAP.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Drug: medroxyprogesterone acetate Drug: Placebo	Phase 2/Phase 3

Detailed Description

Sleep apnea is a common condition affecting both genders. It is affecting more often males than females but after menopause the prevalence of sleep apnea increases in females compared to premenopausal ones and is nearly as high as in males. Continuous positive airway pressure (CPAP) device is the best and standard treatment for the disease. All patients are not adherent to the CPAP treatment and new methods are needed. At the moment no medication is available for sleep apnea. Progesterone hormone is a known respiratory stimulant. Menopause alters significantly women's hormonal balance, for example progesterone levels decrease. Progesterone has been investigated in the treatment of sleep apnea but mostly with male and small populations and the results have been conflicting. Progestins (like medroxyprogesterone acetate, MPA) are female hormones and act through progesterone receptors, so it would be likely women to have less side effects from MPA therapy than men. The purposes of the present study are to evaluate the degree and duration of MPA effect as well as tolerability in postmenopausal women with nasal CPAP treated sleep apnea and to compare the effects with nasal CPAP.

The study is a placebo-controlled double-blind parallel group trial. We included 34 postmenopausal women (17 in placebo and 17 in MPA group) who had been treated for their sleep apnea with CPAP for 1 to 8 years. The trial included measurements at baseline with CPAP, after 14 days of placebo or MPA (60 mg daily) and after three-week washout. The patients discontinued their CPAP one week after the baseline measurements, when they went on with medication. The patients were allowed to continue additional two cycles of MPA treatment before continuing their normal CPAP treatment if they wanted to. Those who continued the additional MPA cycles had the same measurements as in visit 3. The measurements included questionnaires about their symptoms and possible adverse events of MPA, Visual analog scale (VAS) questionnaire with 14 items of sleep quality, Epworth Sleepiness Scale (ESS) and the quality of life questionnaire. Laboratory assays included blood hemoglobin concentration, hematocrit and WBC count, serum creatinine, alanine aminotransferase, total cholesterol, and triglycerides, high-density lipoprotein, estradiol, FSH and thyroid-stimulating hormone and serum MPA concentrations. Overnight polygraphic sleep studies included simultaneous recordings of electroencephalogram (EEG), electro-oculogram (EOG), chin electromyogram (EMG), and electrocardiogram (ECG). Respiration was monitored with a finger probe pulse oximeter (Ohmeda Biox 3700 Pulse Oximeter, BOC Health Care, USA), side-stream capnograph (Datex Normocap® CO2 & O2 Monitor, Instrumentarium, Finland) and the static-charge-sensitive bed (SCSB). During the first visit's CPAP study, Autoset was used in a treatment mode. In the morning after sleep study, subjects completed a questionnaire inquiring their subjective sleep quality during the study night.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Nov 1, 2000

Actual Study Completion Date :

Nov 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: medroxyprogesterone acetate	Drug: medroxyprogesterone acetate MPA hormone therapy 30mg two hours before bedtime and 30mg right before going to bed every night for two weeks period
Placebo Comparator: Placebo Placebo pills taken in the same way as the active comparator	Drug: Placebo Placebo pills were taken in same way as active comparator

Arm

Intervention/Treatment

Active Comparator: medroxyprogesterone acetate

Drug: medroxyprogesterone acetate

MPA hormone therapy 30mg two hours before bedtime and 30mg right before going to bed every night for two weeks period

Placebo Comparator: Placebo

Placebo pills taken in the same way as the active comparator

Drug: Placebo

Placebo pills were taken in same way as active comparator

Outcome Measures

Primary Outcome Measures

polysomnography measures of sleep apnea and sleep [first visit, after 14 days of MPA/placebo use and after 3 weeks washout period]
Sleep stages, apnea-hypopnea index, overnight oxygen saturation values and capnograph values.

Secondary Outcome Measures

subjective questionnaires [first visit, after 14 days of MPA/placebo use and after 3 weeks washout period]
Questionnaires about subjects' symptoms and possible adverse events of MPA, Visual analog scale (VAS) questionnaire with 14 items of sleep quality, Epworth Sleepiness Scale (ESS) and the quality of life questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Years to 77 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

postmenopausal female
regular controls of CPAP treatment in pulmonary clinic and regular use of CPAP device

Exclusion Criteria:

severe or unstable chronic illnesses
heavy current smoking (over 10 cigarettes per day)
medication which effects on the central nervous system
contraindications to progesterone therapy and current participation in any other clinical study