CClinicalTrials.gg
Status unknownNCT03654456Updated May 16, 2019

Impact of Sleep Apnea on Sepsis Mortality

An observational study in Sleep Apnea Syndromes, Sepsis and Mortality, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
280
Ages
20 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Sleep Apnea Syndromes
  • Sepsis
  • Mortality

Keywords

  • obstructive sleep apnea
  • sepsis
  • outcome
  • prognosis
  • sleep-disordered breathing
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 280 is above the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017
  2. Patients who were admitted with a diagnosis of sepsis after the polysomnography
  3. The diagnosis of sepsis fulfilling the clinical criteria

Exclusion criteria

Exclusion Criteria:

  1. Younger than 20 years
  2. Not compatible with a definition of sepsis
  3. subjects with incomplete data
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sepsis patients with OSA

    Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index at least 5/hr with compatible symptoms

    Biological: OSA

  • Sepsis patients without OSA

    Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index less than 5/hr

Interventions

  • BiologicalOSA

    The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.

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What researchers measure

Primary outcomes

  1. Mortality

    percentage of sepsis patients died of sepsis

    Time frame: up to 40 days

Secondary outcomes

  1. Survival time

    Survival time is defined as the length from the date when sepsis is diagnosed to date of discharge or death

    Time frame: up to 40 days

  2. Mortality

    percentage of sepsis patients died of sepsis

    Time frame: 7-day

  3. Mortality

    percentage of sepsis patients died of sepsis

    Time frame: 28-day

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Study locations

1 of 1 sites recruiting
  • Taipei Veterans General Hospital
    Taipei, 112, Taiwan
    • Kun-Ta Chou, M.D · Contact · ale1371@yahoo.com.tw · 922407055
    • Kun-Ta Chou, M.D · Principal investigator
    Recruiting
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References and documents

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 12682500 ↗
  • Huang 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03654456
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Aug 31, 2018
Start date
May 28, 2018
Primary completion
May 27, 2019 (estimated)
Completion
May 27, 2019 (estimated)
Last update
May 16, 2019

Study contacts

Kun-Ta Chou, M.D
Contact
ale1371@yahoo.com.tw
886922407055
Kun-Ta Chou, M.D
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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