Obstructive Sleep Apnea of AdultNCT03618719
Impact of Intermittent Hypoxia on the Function of the Phagocytes
An observational study of Obstructive Sleep Apnea of Adult, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included as well as healthy controls without OSA. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2019to 3 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: <OSA group> Adult Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included. <Control group> Healthy adult controls without OSA
Who may be able to join
- <OSA group> 1. Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis 2. aged 20 years or older 3. Apnea-hypopnea index (AHI) at least 15/hour 4. Willing to participate this study <Control group>
- Healthy controls without OSA
- aged 20 years or older
- AHI less than 5/hour
Who cannot join
- <OSA group>
- OSA patients who do not need continuous positive airway pressure (CPAP) therapy
- OSA Patients have ever received CPAP or other treatment
- aged less than 20 years
- AHI at least 15/hour
- Not willing to participate this study <Control group>
- 1. Apnea-hypopnea index (AHI) equals to or more than 5/hour 2. aged less than 20 years 3. Not willing to participate this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chest department, Taipei Veteran General Hospital
Taipei, 112
Kun-Ta Chou, MD, +886-2-28712121 ext. 3085, hbjoue@vghtpe.gov.tw
About this study
Official title: Impact of Intermittent Hypoxia on Phagocytosis and Sepsis Outcomes: the Potential Role of Statin (Part III: Human Study in 2018-2019)
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included as well as healthy controls without OSA. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy. Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Read the detailed description
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included. Healthy controls without OSA are enrolled, too. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy (not given to controls). Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- obstructive sleep apnea, intermittent hypoxia, granulocyte function, continuous positive airway pressure (CPAP) therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea | Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis | |
| Control | Healthy controls without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granuolocyte function
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Measured: On enrollment
Granuolocyte function
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Measured: 3-month
Granuolocyte function
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS)
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start5 Mar 2019
- Primary completion3 Jul 2019 (estimated)
- Study completion3 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies 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
- Prospective
- Enrolment
- 40 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
- NCT03618719
- Sponsor's protocol ID
- 2016-06-005CC
- Status last verified
- Mar 2019
- First submitted
- 2 Aug 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Hypoxia on Phagocytosis and Sepsis Outcomes: the Potential Role of Statin (Part III: Human Study in 2018-2019)
- ClinicalTrials.gov ID
- NCT03618719
- Acronym / sponsor ID
- 2016-06-005CC
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- obstructive sleep apnea, intermittent hypoxia, granulocyte function, continuous positive airway pressure (CPAP) therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 3 Jul 2019 (estimated)
- Study completion
- 3 Jul 2019 (estimated)
- First posted
- 7 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.
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included as well as healthy controls without OSA. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy. Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Detailed description
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included. Healthy controls without OSA are enrolled, too. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy (not given to controls). Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea | – | –Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis |
| Control | – | –Healthy controls without OSA |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- <OSA group> Adult Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included. <Control group> Healthy adult controls without OSA
Key inclusion criteria (4 listed)
- <OSA group> 1. Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis 2. aged 20 years or older 3. Apnea-hypopnea index (AHI) at least 15/hour 4. Willing to participate this study <Control group>
- Healthy controls without OSA
- aged 20 years or older
- AHI less than 5/hour
Key exclusion criteria (7 listed)
- <OSA group>
- OSA patients who do not need continuous positive airway pressure (CPAP) therapy
- OSA Patients have ever received CPAP or other treatment
- aged less than 20 years
- AHI at least 15/hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Granuolocyte function
Time frame: On enrollment
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Granuolocyte function
Time frame: 3-month
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Granuolocyte function
Time frame: 6-month
Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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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 Obstructive Sleep Apnea of Adult, 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 4 inclusion and 7 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 12 Mar 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?
Granuolocyte function (time frame: On enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.