OSANCT03885440
Age and Sleep Apnea Syndrome
An observational study of OSA and Age Problem, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- OSA, Age Problem
- What is being tested?
- Age and OSA
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with sleep complaints
Who may be able to join
- Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital
Who cannot join
- Patients who ever received treatment for OSA
- Patients cannot tolerate PSG examination
- Patients cannot complete the questionnaires before and after PSG examination
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chest department, Taipei Veteran General Hospital
Taipei, 112
Hwa-Yen Chiu, MD, +886-2-28712121 ext. 7563, hychiu@vghtpe.gov.tw
Kun-Ta Chou, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- OSA, Age Problem
- Being tested
- Age, OSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgeOther
Age<40 years old is chosen as the cutoff value.
OSAOther
The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Young adult, without OSAS | 20<=Age<40 years old, apnea-hypopnea index(AHI)<5 Receives: Other: Age | |
| Young adult, with OSAS | 20<=Age<40 years old, AHI>=5 Receives: Other: Age; Other: OSA | |
| older adult, without OSAS | Age>=40 years old, AHI<5 | |
| older adult, with OSAS | Age>=40 years old, AHI>=5 Receives: Other: OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index(AHI)
Counts of apnea/hypopnea events per hour
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Body mass index(BMI)
The body mass divided by the square of the body height.
Measured: through study completion, an average of 1 year
Posterior airway space (PAS)
The diameter from supramentale to gonion.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
arousal index
The number of arousals and awakenings as a frequency per hour of sleep.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start8 Apr 2019
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885440
- Sponsor's protocol ID
- 2018-10-002CC
- Status last verified
- Apr 2019
- First submitted
- 16 Mar 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chiu HY, Chou KT, Su KC, Lin FC, Liu YY, Shiao TH, Chen YM. Obstructive sleep apnea in young Asian adults with sleep-related complaints. Sci Rep. 2022 Nov 29;12(1):20582. doi: 10.1038/s41598-022-25183-5.
PubMed 36447027
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Sleep Apnea Syndrome: Clinical Features and Outcomes
- ClinicalTrials.gov ID
- NCT03885440
- Acronym / sponsor ID
- 2018-10-002CC
- Conditions
- OSA, Age Problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young adult, without OSAS | – | Other: Age20<=Age<40 years old, apnea-hypopnea index(AHI)<5 |
| Young adult, with OSAS | – | Other: Age, Other: OSA20<=Age<40 years old, AHI>=5 |
| older adult, without OSAS | – | –Age>=40 years old, AHI<5 |
| older adult, with OSAS | – | Other: OSAAge>=40 years old, AHI>=5 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sleep complaints
Key inclusion criteria (1 listed)
- Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital
Key exclusion criteria (3 listed)
- Patients who ever received treatment for OSA
- Patients cannot tolerate PSG examination
- Patients cannot complete the questionnaires before and after PSG examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AgeAge<40 years old is chosen as the cutoff value. | Other | Young adult, with OSAS, Young adult, without OSAS |
| OSAThe diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms. | Other | Young adult, with OSAS, older adult, with OSAS |
Primary outcome
Apnea-hypopnea index(AHI)
Time frame: through study completion, an average of 1 year
Counts of apnea/hypopnea events per hour
6 secondary outcomes
Body mass index(BMI)
Time frame: through study completion, an average of 1 year
Posterior airway space (PAS)
Time frame: through study completion, an average of 1 year
Number of participants with comorbidities
Time frame: through study completion, an average of 1 year
Sleep efficiency
Time frame: through study completion, an average of 1 year
arousal index
Time frame: through study completion, an average of 1 year
oxygen desaturation index
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 36447027Chiu HY, Chou KT, Su KC, Lin FC, Liu YY, Shiao TH, Chen YM. Obstructive sleep apnea in young Asian adults with sleep-related complaints. Sci Rep. 2022 Nov 29;12(1):20582. doi: 10.1038/s41598-022-25183-5.
- Individual participant dataSharing planned: Undecided
Related trials for OSA
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
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Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chest department, Taipei Veteran General Hospital
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA and Age Problem, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index(AHI) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.