Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): medroxyprogesterone acetate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MPA hormone therapy 30mg two hours before bedtime and 30mg right before going to bed every night for two weeks period; Placebo pills were taken in same way as active comparator
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep apnea; women; postmenopause; hormone treatment