Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01472315
First received: October 3, 2011
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Sleep Apnea
Drug: medroxyprogesterone acetate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • polysomnography measures of sleep apnea and sleep [ Time Frame: first visit, after 14 days of MPA/placebo use and after 3 weeks washout period ] [ Designated as safety issue: No ]
    Sleep stages, apnea-hypopnea index, overnight oxygen saturation values and capnograph values.


Secondary Outcome Measures:
  • subjective questionnaires [ Time Frame: first visit, after 14 days of MPA/placebo use and after 3 weeks washout period ] [ Designated as safety issue: No ]
    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


Enrollment: 34
Study Start Date: January 2000
Study Completion Date: November 2000
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   42 Years to 77 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472315

Locations
Finland
Sleep Research Unit, Department of Physiology, Turku University
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01472315     History of Changes
Other Study ID Numbers: 1/2000-15
Study First Received: October 3, 2011
Last Updated: March 8, 2013
Health Authority: Finland: National Advisory Board on Health Care Ethics

Keywords provided by Turku University Hospital:
sleep apnea
women
postmenopause
hormone treatment

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014