Age and Sleep Apnea Syndrome
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ClinicalTrials.gov Identifier: NCT03885440 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : April 9, 2019
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Condition or disease | Intervention/treatment |
---|---|
OSA Age Problem | Other: Age Other: OSA |
Study Type : | Observational |
Estimated Enrollment : | 3000 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Age and Sleep Apnea Syndrome: Clinical Features and Outcomes |
Actual Study Start Date : | April 8, 2019 |
Estimated Primary Completion Date : | June 30, 2019 |
Estimated Study Completion Date : | September 30, 2019 |
Group/Cohort | Intervention/treatment |
---|---|
Young adult, without OSAS
20<=Age<40 years old, apnea-hypopnea index(AHI)<5
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Other: Age
Age<40 years old is chosen as the cutoff value. |
Young adult, with OSAS
20<=Age<40 years old, AHI>=5
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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. |
- Apnea-hypopnea index(AHI) [ Time Frame: through study completion, an average of 1 year ]Counts of apnea/hypopnea events per hour
- Body mass index(BMI) [ Time Frame: through study completion, an average of 1 year ]The body mass divided by the square of the body height.
- Posterior airway space (PAS) [ Time Frame: through study completion, an average of 1 year ]The diameter from supramentale to gonion.
- Number of participants with comorbidities [ Time Frame: through study completion, an average of 1 year ]Self-reported comorbidities including cardiovascular disease, stroke, hypertension, diabetes mellitus, hyperlipidemia, lung disease, anxiety, depression.
- Sleep efficiency [ Time Frame: through study completion, an average of 1 year ]The ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed.
- arousal index [ Time Frame: through study completion, an average of 1 year ]The number of arousals and awakenings as a frequency per hour of sleep.
- oxygen desaturation index [ Time Frame: through study completion, an average of 1 year ]The number of times per hour of sleep that the blood's oxygen level drop by 4% from baseline.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885440
Taiwan | |
Chest department, Taipei Veteran General Hospital | Recruiting |
Taipei City, Taiwan, 112 | |
Contact: Hwa-Yen Chiu, MD +886-2-28712121 ext 7563 hychiu@vghtpe.gov.tw | |
Principal Investigator: Kun-Ta Chou, MD | |
Principal Investigator: Hwa-Yen Chiu, MD |
Responsible Party: | vghtpe user, Principal Investigator, Medical Doctor, Taipei Veterans General Hospital, Taiwan |
ClinicalTrials.gov Identifier: | NCT03885440 |
Other Study ID Numbers: |
2018-10-002CC |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | April 9, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |