Metabolic Profiling in Patients With Obstructive Sleep Apnea: From Plasma to Hypoxic Cell Model of Peripheral Monocyte

NCT02130050 | Unknown DMC

• 1 other identifier: 201401106RINB
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This three-year project aims to

1. 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. 2.Identify the candidate metabolites involved in biologic pathways attributing to OSA phenotyping and response to CPAP treatment
3. 3.Validate candidate metabolites 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• Metabolites in the intermittent-hypoxia model of peripheral monocytes

  6 months

Study Arms (2)

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)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

moderate to severe OSA from primary care clinic friends and families from recommendation of OSA patients

You may qualify if:

• 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

You may not qualify if:

• 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
• sleepy driver
• using maintenance medications
• Control subjects
• Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
• non-sleepy
• no OSA confirmed by home sleep study (AHI\<5/hr)
• unwilling or unable to perform testing procedure

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Peilin Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 2, 2014

Record last verified: 2014-04

Locations

TW (1)