Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities
medroxyprogesterone acetate
+ Placebo
Apnée+5
+ Maladies du système nerveux
+ Troubles respiratoires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2000
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.34 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 42 à 77 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
Comparateur actifGroupe II
PlaceboObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Sleep Research Unit, Department of Physiology, Turku University
Turku, FinlandOuvrir Sleep Research Unit, Department of Physiology, Turku University dans Google Maps