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Age and Sleep Apnea Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885440
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief 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.

Condition or disease Intervention/treatment
OSA Age Problem 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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  1. Apnea-hypopnea index(AHI) [ Time Frame: through study completion, an average of 1 year ]
    Counts of apnea/hypopnea events per hour


Secondary Outcome Measures :
  1. 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.

  2. Posterior airway space (PAS) [ Time Frame: through study completion, an average of 1 year ]
    The diameter from supramentale to gonion.

  3. 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.

  4. 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.

  5. 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.

  6. 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
Study Population
Adults with sleep complaints
Criteria

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

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases