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OSA with hypoxia for Hypoxia

N/A
Recruiting
Led By Jean-Marc Schwarz, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. Our overarching hypothesis is that patients with OSA and hypoxia (H-OSA) have greater degrees of insulin resistance in both liver and adipose tissue when compared to those without hypoxia (NH-OSA) thus leading to increased risk for the development of diabetes in the former group.

Eligible Conditions
  • Hypoxia
  • Obstructive Sleep Apnea
  • Insulin Resistance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fractional De Novo Lipogenesis (DNL, %)
Liver fat Fraction (%)
Secondary study objectives
Insulin secretion rate (picomol/min)
Total fat mass (grams)

Side effects data

From 2014 Phase 2 trial • 53 Patients • NCT01187771
32%
Respiratory tract infections
21%
Drowsy driving
18%
Injuries NEC
14%
Epidermal and dermal conditions
14%
Aural disorders NEC
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Gallbladder disorders
7%
Respiratory disorders NEC
7%
Female reproductive tract infections and inflammations
7%
Upper respiratory tract disorders (excl infections)
7%
Tendon, ligament and cartilage disorders
7%
Headaches
4%
Muscle disorders
4%
Bone disorders (excl congenital and fractures)
4%
Diverticular disorders
4%
Procedural related injuries and complicatins NEC
4%
Skin and subcutaneous tissue infections and infestations
4%
Gastrointestinal motility
4%
Musculoskeletal and connective tissue disorders NEC
4%
Mood disorders and disturbances NEC
4%
Glucose metabolism disorders
4%
Demyelinating disorders
4%
Suicidal and self-injurious behaviors NEC
4%
Depressed mood disorders and disturbances
4%
Genitourinary tract disorders NEC
4%
Medication errors
4%
Urinary tract signs and symptoms
4%
Anxiety disorders and symptoms
4%
Gastrointestinal infections
4%
Ocular infections, irritations and inflammations
4%
Bone and joint injuries
4%
Coronary artery disrders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure

Trial Design

2Treatment groups
Experimental Treatment
Group I: OSA without hypoxiaExperimental Treatment1 Intervention
People with obstructive sleep apnea and without hypoxia before and after treatment with continuous positive airway pressure
Group II: OSA with hypoxiaExperimental Treatment1 Intervention
People with obstructive sleep apnea and hypoxia before and after treatment with continuous positive airway pressure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,831 Total Patients Enrolled
1 Trials studying Hypoxia
100 Patients Enrolled for Hypoxia
University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,826 Total Patients Enrolled
22 Trials studying Hypoxia
11,120 Patients Enrolled for Hypoxia
Jean-Marc Schwarz, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
125 Total Patients Enrolled
~2 spots leftby Dec 2024
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