Sleep Apnea SyndromesNCT03654456
Impact of Sleep Apnea on Sepsis Mortality
An observational study of Sleep Apnea Syndromes and Sepsis, 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 mortality of sepsis patients with versus without 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
- Sleep Apnea Syndromes, Sepsis, Mortality
- What is being tested?
- OSA
- How many people
- 280 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2018to 27 May 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: Sepsis Patients who had received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled.
Who may be able to join
- Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017
- Patients who were admitted with a diagnosis of sepsis after the polysomnography
- The diagnosis of sepsis fulfilling the clinical criteria
Who cannot join
- Younger than 20 years
- Not compatible with a definition of sepsis
- subjects with incomplete data
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Kun-Ta Chou, M.D, 922407055, ale1371@yahoo.com.tw
Kun-Ta Chou, M.D
About this study
Official title: The Impact of Sleep Apnea on the Mortality of Sepsis - A Retrospective Study
By clinical record review, this retrospective study aims to compare the mortality of sepsis patients with versus without 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 mortality of sepsis patients with versus without obstructive sleep apnea (OSA). Patients with a diagnosis of sepsis, who had received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography and details related to sepsis (source of infection, number of organ dysfunction at initial diagnosis of sepsis and survival time) will be collected. The start of the survival time (follow-up time) is the date when sepsis is diagnosed. The end of the survival time (follow-up time) is the date of death or end of hospitalization (date of discharge). Survival analyses will be performed.
- Conditions
- Sleep Apnea Syndromes, Sepsis, Mortality
- Being tested
- OSA
- Keywords
- obstructive sleep apnea, sepsis, outcome, prognosis, sleep-disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes, Sepsis, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSABiological
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 |
|---|---|---|
| Sepsis patients with OSA | Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index at least 5/hr with compatible symptoms Receives: Biological: OSA | |
| Sepsis patients without OSA | Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index less than 5/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
percentage of sepsis patients died of sepsis
Measured: up to 40 days
Secondary outcomes (3)
Survival time
Survival time is defined as the length from the date when sepsis is diagnosed to date of discharge or death
Measured: up to 40 days
Mortality
percentage of sepsis patients died of sepsis
Measured: 7-day
Mortality
percentage of sepsis patients died of sepsis
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start28 May 2018
- Primary completion27 May 2019 (estimated)
- Study completion27 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kun-Ta Chou, M.D, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654456
- Sponsor's protocol ID
- 2018-06-019AC
- Status last verified
- May 2019
- First submitted
- 24 Jul 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
PubMed 12682500Huang CY, Chen YT, Wu LA, Liu CJ, Chang SC, Perng DW, Chen YM, Chen TJ, Lee YC, Chou KT. Sleep apnoea patients have higher mortality when confronting sepsis. Eur J Clin Invest. 2014 Jan;44(1):38-45. doi: 10.1111/eci.12187. Epub 2013 Nov 11.
PubMed 24117403
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleep Apnea on the Mortality of Sepsis - A Retrospective Study
- ClinicalTrials.gov ID
- NCT03654456
- Acronym / sponsor ID
- 2018-06-019AC
- Conditions
- Sleep Apnea Syndromes, Sepsis, Mortality
- Keywords
- obstructive sleep apnea, sepsis, outcome, prognosis, sleep-disordered breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 28 May 2018 (actual)
- Primary completion
- 27 May 2019 (estimated)
- Study completion
- 27 May 2019 (estimated)
- First posted
- 31 Aug 2018 (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 mortality of sepsis patients with versus without obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.
Detailed description
This retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea (OSA). Patients with a diagnosis of sepsis, who had received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography and details related to sepsis (source of infection, number of organ dysfunction at initial diagnosis of sepsis and survival time) will be collected. The start of the survival time (follow-up time) is the date when sepsis is diagnosed. The end of the survival time (follow-up time) is the date of death or end of hospitalization (date of discharge). Survival analyses will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis patients with OSA | – | Biological: OSASepsis patients who received a prior polysomnography showing an apnea-hypopnea index at least 5/hr with compatible symptoms |
| Sepsis patients without OSA | – | –Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index less than 5/hr |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis Patients who had received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled.
Key inclusion criteria (3 listed)
- Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017
- Patients who were admitted with a diagnosis of sepsis after the polysomnography
- The diagnosis of sepsis fulfilling the clinical criteria
Key exclusion criteria (3 listed)
- Younger than 20 years
- Not compatible with a definition of sepsis
- subjects with incomplete data
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 |
|---|---|---|
| OSAThe diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms. | Biological | Sepsis patients with OSA |
Primary outcome
Mortality
Time frame: up to 40 days
percentage of sepsis patients died of sepsis
3 secondary outcomes
Survival time
Time frame: up to 40 days
Mortality
Time frame: 7-day
Mortality
Time frame: 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Background: PubMed 12682500Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
- Results publication: PubMed 24117403Huang CY, Chen YT, Wu LA, Liu CJ, Chang SC, Perng DW, Chen YM, Chen TJ, Lee YC, Chou KT. Sleep apnoea patients have higher mortality when confronting sepsis. Eur J Clin Invest. 2014 Jan;44(1):38-45. doi: 10.1111/eci.12187. Epub 2013 Nov 11.
- Individual participant dataSharing planned: Undecided
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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.
Kun-Ta Chou, M.D principal investigator
Taipei Veterans General Hospital, 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 Sleep Apnea Syndromes and Sepsis, 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 3 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 16 May 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?
Contact Kun-Ta Chou, M.D (886922407055, ale1371@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 40 days). 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 NCT03654456, which also lists 2 linked publications.
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 16 May 2019.