Obstructive Sleep ApneaNCT02130050
Metabolic Profiling in Patients With Obstructive Sleep Apnea: From Plasma to Hypoxic Cell Model of Peripheral Monocyte
An observational study of Obstructive Sleep Apnea and Cardiovascular Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This three-year project aims to 1. Profile the differentially expressed metabolites in healthy patients with severe Obstructive sleep apnea (OSA) before and after six-month continuous positive airway pressure (CPAP) treatment 2. Read more about this study
- Who is it for?
- Ages 20 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Cardiovascular Disease
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Apr 2015
- 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 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: moderate to severe OSA from primary care clinic friends and families from recommendation of OSA patients
Who may be able to join
- male patients aged 20 to 90 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Who cannot join
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
Show all 20Show fewer
- enrolled in other trials in the study period
- other sleep disorders
- sleepy driver
- using maintenance medications
- Control subjects
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- using maintenance medications
Trial locations and contacts
1 site in 1 country.
About this study
This three-year project aims to
- Profile the differentially expressed metabolites in healthy patients with severe Obstructive sleep apnea (OSA) before and after six-month continuous positive airway pressure (CPAP) treatment
- Identify the candidate metabolites involved in biologic pathways attributing to OSA phenotyping and response to CPAP treatment
- Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
Read the detailed description
Obstructive sleep apnea is characterized with chronic intermittent hypoxia and sleep fragmentations. The sequels of OSA included excessive daytime sleepiness, cardiovascular disease, and neurocognitive dysfunction which could be reversed with continuous positive airway pressure (CPAP). A couple of biologic pathways have been associated with the phenotyping of OSA which included craniofacial morphology, ventilator control, body fat distribution/metabolism, and sleepiness vulnerability. Metabolomics, a recently developed technique to detect metabolomic profiles, could help to understand the disease pathophysiology and explore biomarkers. So far, only one paper studied the metabolomic profile in patients with OSA where putative identifications of 14 statistically significant features were profiled. Our pilot study comparing the metabolic profiling in OSA patients randomly assigned to therapeutic and subtherapeutic CPAP showed CPAP treatment did alter the metabolomic profile. Seventeen metabolites in three biologic pathways and 13 metabolites in the six biologic pathways were identified in therapeutic and subtherapeutic CPAP, respectively. Sixteen metabolites in three biologic pathways were identified by comparing two groups. However, there were a couple of weakness in studies in the literature and ours. Furthermore, the direct causal relationship of the profiled metabolites and OSA needs to be clarified. Therefore, we plan to compare the metabolic profiling in control subjects and healthy OSA patients, before and after six-month CPAP treatment, to identify candidate metabolites involved in biologic pathways attributing to phenotyping and response to CPAP treatment. Furthermore, candidate metabolites involved in biologic pathways, especially pathways of ROS, inflammation, and metabolism, will be validated in the intermittent hypoxia model of peripheral monocytes.
- Conditions
- Obstructive Sleep Apnea, Cardiovascular Disease
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Cardiovascular disease, Polysomnography, Metabolomic
- Medical subject headings
- Sleep Apnea, Obstructive, Cardiovascular Diseases
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 |
|---|---|---|
| OSA Patient | •male patients aged 30 to 65 yr who are newly diagnosed as severe OSA (AHI >=30/hr) | |
| Control subjects: | •male control subjects are recruited from Heath Check-up Center. Subjects who are matched with OSA patients at age (+/-2 yrs), body height (+/-3cm) and body weight (<100 kg: +/-3kg, >100 kg: +/-4kg) are screened. Only subjects who are not sleepy (ESS<10) and have no OSA (AHI<5/hr PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expressed metabolites profiles
Profiling the differentially expressed metabolites in control subjects and healthy patients with severe OSA before and after six-month CPAP treatment
Measured: 6 months
Secondary outcomes (1)
Metabolites in the intermittent-hypoxia model of peripheral monocytes
Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peilin Lee, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130050
- Sponsor's protocol ID
- 201401106RINB
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profiling in Patients With Obstructive Sleep Apnea: From Plasma to Hypoxic Cell Model of Peripheral Monocyte
- ClinicalTrials.gov ID
- NCT02130050
- Acronym / sponsor ID
- 201401106RINB
- Conditions
- Obstructive Sleep Apnea, Cardiovascular Disease
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Cardiovascular disease, Polysomnography, Metabolomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 2 May 2014 (estimated)
- 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.
This three-year project aims to
- Profile the differentially expressed metabolites in healthy patients with severe Obstructive sleep apnea (OSA) before and after six-month continuous positive airway pressure (CPAP) treatment
- Identify the candidate metabolites involved in biologic pathways attributing to OSA phenotyping and response to CPAP treatment
- Validate candidate metabolites in the intermittent-hypoxia model of peripheral monocytes
Detailed description
Obstructive sleep apnea is characterized with chronic intermittent hypoxia and sleep fragmentations. The sequels of OSA included excessive daytime sleepiness, cardiovascular disease, and neurocognitive dysfunction which could be reversed with continuous positive airway pressure (CPAP). A couple of biologic pathways have been associated with the phenotyping of OSA which included craniofacial morphology, ventilator control, body fat distribution/metabolism, and sleepiness vulnerability. Metabolomics, a recently developed technique to detect metabolomic profiles, could help to understand the disease pathophysiology and explore biomarkers. So far, only one paper studied the metabolomic profile in patients with OSA where putative identifications of 14 statistically significant features were profiled. Our pilot study comparing the metabolic profiling in OSA patients randomly assigned to therapeutic and subtherapeutic CPAP showed CPAP treatment did alter the metabolomic profile. Seventeen metabolites in three biologic pathways and 13 metabolites in the six biologic pathways were identified in therapeutic and subtherapeutic CPAP, respectively. Sixteen metabolites in three biologic pathways were identified by comparing two groups. However, there were a couple of weakness in studies in the literature and ours. Furthermore, the direct causal relationship of the profiled metabolites and OSA needs to be clarified. Therefore, we plan to compare the metabolic profiling in control subjects and healthy OSA patients, before and after six-month CPAP treatment, to identify candidate metabolites involved in biologic pathways attributing to phenotyping and response to CPAP treatment. Furthermore, candidate metabolites involved in biologic pathways, especially pathways of ROS, inflammation, and metabolism, will be validated in the intermittent hypoxia model of peripheral monocytes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA Patient | – | –•male patients aged 30 to 65 yr who are newly diagnosed as severe OSA (AHI >=30/hr) |
| Control subjects: | – | –•male control subjects are recruited from Heath Check-up Center. Subjects who are matched with OSA patients at age (+/-2 yrs), body height (+/-3cm) and body weight (<100 kg: +/-3kg, >100 kg: +/-4kg) are screened. Only subjects who are not sleepy (ESS<10) and have no OSA (AHI<5/hr PSG) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe OSA from primary care clinic friends and families from recommendation of OSA patients
Key inclusion criteria (5 listed)
- male patients aged 20 to 90 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Key exclusion criteria (20 listed)
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
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
The expressed metabolites profiles
Time frame: 6 months
Profiling the differentially expressed metabolites in control subjects and healthy patients with severe OSA before and after six-month CPAP treatment
1 secondary outcome
Metabolites in the intermittent-hypoxia model of peripheral monocytes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
Related trials for Obstructive Sleep Apnea
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
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Development of a Multimodal Deep Learning Model for Pediatric Patients
Pediatric Obstructive Sleep Apnea, Polysomnography
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.
Peilin Lee, M.D. principal investigator
National Taiwan University Hospital
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 and Cardiovascular Disease, run by National Taiwan University Hospital 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 5 inclusion and 20 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 2 May 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expressed metabolites profiles (time frame: 6 months). 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 2 May 2014.