Sleep-disordered Breathing in Postmenopausal Women

Completed

• Conditions: Sleep Apnea
• Interventions: Procedure: CPAP treatment

• Registration Number: NCT01825291
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1999-01
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• patient with sleep apnea
• CPAP treatment started and continued

Exclusion Criteria

• no CPAP treatment started

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sleep apnea	CPAP treatment	-

Primary Outcome Measures

Name	Time	Method
Change in the consumption of medication of co-morbidities of sleep apnea	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.