NCT Number: NCT01825291
Sleep-disordered Breathing in Postmenopausal Women
The purpose of this study is to investigate the effectiveness of CPAP treatment to co-morbidities of sleep apnea by looking the change of the consumption of medication of the co-morbidities before and after starting the CPAP treatment.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patient with sleep apnea
- CPAP treatment started and continued
Exclusion criteria
- no CPAP treatment started
Treatment and study plan
Primary outcomes
-
Change in the consumption of medication of co-morbidities of sleep apnea
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Turku University Hospital
Other Gov
Registry information
Official study title
Sleep-disordered Breathing in Postmenopausal Women and CPAP Treatment
Important dates
- Study start
- 1999
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Apr 5, 2013
- Registry last updated
- May 9, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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