- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01825291
Sleep-disordered Breathing in Postmenopausal Women
Sleep-disordered Breathing in Postmenopausal Women and CPAP Treatment
Aperçu de l'étude
Description détaillée
Sleep-disordered breathing (SDB) is frequently linked with cardiovascular diseases including stroke and type 2 diabetes, which increase the indirect costs of sleep apnea. Also non-cardiovascular co-morbidities are possible but seldom studied. CPAP treatment reverses the increased healthcare utilization seen before the sleep apnea diagnosis.
Previous studies addressing the cardiovascular co-morbidities in SDB have focused on obstructive sleep apnea and in male populations, but not on partial upper airway obstruction. Partial upper airway obstruction is common in both genders but especially in women. According to investigators' clinical experience, women with partial upper airway obstruction are especially likely to have severe symptoms from their SDB. There are scarce data on cardiovascular co-morbidities associated with partial upper airway obstruction and the female gender.
To study the prevalence of co-morbidities adding to the burden of SDB (periodic obstructive breathing and partial upper airway obstruction), investigators applied a conservative but robust strategy using the governmental database of medication reimbursed by the public health insurance system. Investigators analyzed both the cardiovascular and non-cardiovascular co-morbidities in our clinical population of SDB, separately in patients with periodic obstructive breathing or with partial upper airway obstruction during sleep.Investigators found that concomitant diseases ware common in SDB. Asthma and/or COPD were surprisingly frequent, and also chronic hypertension had an increased prevalence. In addition, males had diabetes mellitus and females hypothyroidism more than general population. The results emphasize the importance of diagnosis and treatment of the co-morbidities such as asthma, COPD, hypertension, diabetes and thyroid insufficiency regardless if the patient has partial upper airway obstruction or obstructive sleep apnea.
Now, investigators hypothesize that CPAP treatment reduces the consumption of medication of the co-morbidities of sleep apnea. Therefore, a retrospective analyze of 5 year before and 5 year after starting the CPAP treatment the medication consumption of the same population previously used will be conducted. To do this, the governmental database of medication reimbursed by the public health insurance system will be used.
Type d'étude
Inscription (Anticipé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- patient with sleep apnea
- CPAP treatment started and continued
Exclusion Criteria:
- no CPAP treatment started
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
sleep apnea
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in the consumption of medication of co-morbidities of sleep apnea
Délai: 5 year before CPAP treatment and 5 year after CPAP treatment
|
The amount of medication used gathered from the National Agency for Medicines and Social Insurance Institution database.
|
5 year before CPAP treatment and 5 year after CPAP treatment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1/2000
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