Age and Sleep Apnea Syndrome

Age and Sleep Apnea Syndrome: Clinical Features and Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: OSA; Age Problem
• Intervention / Treatment: Other: Age; Other: OSA

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 112
    • Recruiting
    • Chest department, Taipei Veteran General Hospital
    • Contact: Hwa-Yen Chiu, MD; Phone Number: 7563 +886-2-28712121; Email: hychiu@vghtpe.gov.tw
    • Principal Investigator: Kun-Ta Chou, MD
    • Principal Investigator: Hwa-Yen Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with sleep complaints

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young adult, without OSAS; 20<=Age<40 years old, apnea-hypopnea index(AHI)<5	Other: Age; Age<40 years old is chosen as the cutoff value.
Young adult, with OSAS; 20<=Age<40 years old, AHI>=5	Other: Age; Age<40 years old is chosen as the cutoff value.; Other: OSA; The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.
older adult, without OSAS; Age>=40 years old, AHI<5
older adult, with OSAS; Age>=40 years old, AHI>=5	Other: OSA; The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index(AHI)	Counts of apnea/hypopnea events per hour	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index(BMI)	The body mass divided by the square of the body height.	through study completion, an average of 1 year
Posterior airway space (PAS)	The diameter from supramentale to gonion.	through study completion, an average of 1 year
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
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
arousal index	The number of arousals and awakenings as a frequency per hour of sleep.	through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): September 30, 2019

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: 2018-10-002CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No