Age and Sleep Apnea Syndrome

OSA Clinical Trial

Official title:

Age and Sleep Apnea Syndrome: Clinical Features and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885440
• Other study ID #: 2018-10-002CC
• Status: Recruiting
• Start date: April 8, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: April 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By clinical record review, this retrospective study aims to compare the different age groups of patients with obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

Description:

This retrospective study aims to compare the characteristics of patients with obstructive sleep apnea (OSA). Patients with sleep problem and received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2016 to Dec. 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index(AHI) at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography, comorbidities and details related to upper airway structure will be collected. The charactereistics would be compared with Student's t tests, Mann-Whitney U tests, or Chi square tests if appropriated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital

Exclusion Criteria:

• Patients who ever received treatment for OSA

• Patients cannot tolerate PSG examination

• Patients cannot complete the questionnaires before and after PSG examination

Related Conditions & MeSH terms

• Age Problem
• OSA
• Sleep Apnea Syndromes

Intervention

Other:
• Age
Age<40 years old is chosen as the cutoff value.
• OSA
The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.

Locations

Country	Name	City	State
Taiwan	Chest department, Taipei Veteran General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index(AHI)	Counts of apnea/hypopnea events per hour	through study completion, an average of 1 year
Secondary	Body mass index(BMI)	The body mass divided by the square of the body height.	through study completion, an average of 1 year
Secondary	Posterior airway space (PAS)	The diameter from supramentale to gonion.	through study completion, an average of 1 year
Secondary	Number of participants with comorbidities	Self-reported comorbidities including cardiovascular disease, stroke, hypertension, diabetes mellitus, hyperlipidemia, lung disease, anxiety, depression.	through study completion, an average of 1 year
Secondary	Sleep efficiency	The ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed.	through study completion, an average of 1 year
Secondary	arousal index	The number of arousals and awakenings as a frequency per hour of sleep.	through study completion, an average of 1 year
Secondary	oxygen desaturation index	The number of times per hour of sleep that the blood's oxygen level drop by 4% from baseline.	through study completion, an average of 1 year