Sleep-disordered Breathing in Postmenopausal Women

Sleep Apnea Clinical Trial

Official title:

Sleep-disordered Breathing in Postmenopausal Women and CPAP Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825291
• Other study ID #: 1/2000
• Status: Completed
• Start date: January 1999
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patient with sleep apnea

• CPAP treatment started and continued

Exclusion Criteria:

• no CPAP treatment started

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Procedure:
• CPAP treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the consumption of medication of co-morbidities of sleep apnea	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