Age and Sleep Apnea Syndrome

April 8, 2019 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 112
        • Recruiting
        • Chest department, Taipei Veteran General Hospital
        • Contact:
        • Principal Investigator:
          • Kun-Ta Chou, MD
        • Principal Investigator:
          • Hwa-Yen Chiu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea index(AHI)
Time Frame: through study completion, an average of 1 year
Counts of apnea/hypopnea events per hour
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
Posterior airway space (PAS)
Time Frame: through study completion, an average of 1 year
The diameter from supramentale to gonion.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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