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Procedure
CPAP for Obstructive Sleep Apnea
Phase < 1
Waitlist Available
Led By Krishna Sundar
Research Sponsored by University of Utah
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 baseline, after 3 months, and after 6 months on trial
Awards & highlights
Study Summary
This trial will study whether CPAP is an effective treatment for obstructive sleep apnea in patients with polycythemia vera or essential thrombocythemia.
Who is the study for?
This trial is for people with polycythemia vera or essential thrombocythemia who also have obstructive sleep apnea. Participants should be on a stable treatment dose, not smoke heavily, and agree to use effective contraception. They can't join if they've used certain medications recently, had other cancers (except some skin cancers), or have severe illnesses like advanced liver disease.Check my eligibility
What is being tested?
The study tests how well CPAP machines help patients with specific blood conditions manage their sleep apnea. It involves using the CPAP device regularly and filling out questionnaires to monitor changes in sleep quality and overall health.See study design
What are the potential side effects?
CPAP side effects may include discomfort while wearing the mask, dry nose or throat, nasal congestion, headaches, bloating and difficulty falling asleep initially.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, after 3 months, and after 6 months on trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 3 months, and after 6 months on trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in JAK2 V617F allele burden
Change in Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)
Other outcome measures
Leucocytes, platelets, red cell counts, and tumor necrosis factor (TNF) analysis
Proportion of patients with a diagnosis of obstructive sleep apnea (OSA)
Thrombotic and inflammatory marker levels for all patients
Side effects data
From 2014 Phase 2 trial • 53 Patients • NCT0118777132%
Respiratory tract infections
21%
Drowsy driving
18%
Injuries NEC
14%
Aural disorders NEC
14%
Epidermal and dermal conditions
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Upper respiratory tract disorders (excl infections)
7%
Headaches
7%
Gallbladder disorders
7%
Tendon, ligament and cartilage disorders
7%
Female reproductive tract infections and inflammations
7%
Respiratory disorders NEC
4%
Anxiety disorders and symptoms
4%
Suicidal and self-injurious behaviors NEC
4%
Gastrointestinal infections
4%
Gastrointestinal motility
4%
Procedural related injuries and complicatins NEC
4%
Glucose metabolism disorders
4%
Genitourinary tract disorders NEC
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Ocular infections, irritations and inflammations
4%
Diverticular disorders
4%
Bone and joint injuries
4%
Muscle disorders
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
4%
Urinary tract signs and symptoms
4%
Demyelinating disorders
4%
Depressed mood disorders and disturbances
4%
Mood disorders and disturbances NEC
4%
Skin and subcutaneous tissue infections and infestations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort II: (CPAP treatment)Experimental Treatment2 Interventions
Patients diagnosed with OSA and prescribed a CPAP machine for treatment receive continuous treatment with CPAP for 6 months.
Group II: Cohort I (observation)Active Control2 Interventions
Patients not diagnosed with OSA undergo observation for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1680
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,095 Previous Clinical Trials
1,775,577 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,145 Total Patients Enrolled
Krishna SundarPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with obstructive sleep apnea (OSA) and your sleep study score is 5 or higher.You have not taken JAK2 inhibitors in the 6 months leading up to the study.You have used TNF inhibitors before or are currently using them.If you have a high score on the STOP-BANG questionnaire, which includes questions about snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender, you may not be able to participate in the study.You had a different type of cancer before, except for non-melanoma skin cancer, and either you have been cancer-free for at least 2 years, or your doctor expects you to live for more than 2 years without treatment, for example, if you have low-risk localized prostate cancer.You are able to perform daily activities without any problems or with some mild symptoms.You have been using CPAP or other treatments for sleep apnea for a long time. You can only have used CPAP for up to 6 months continuously in the last 5 years.You have an autoimmune disease that needs treatment with drugs that affect the immune system.You have been diagnosed with essential thrombocythemia or polycythemia vera according to specific medical criteria before the screening.You have smoked less than 20 packs of cigarettes per year or you quit smoking at least 3 years ago and do not have any current symptoms of COPD. Your lung function tests are normal.Women who can have babies need to have a negative pregnancy test before joining the study.You have a serious health condition like heart disease, kidney failure, or advanced liver disease, or an uncontrolled severe infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II: (CPAP treatment)
- Group 2: Cohort I (observation)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this trial limited to those aged 55 or younger?
"The eligibility criteria for this medical trial includes a minimum age of 30 and an upper limit of 85."
Answered by AI
Could you please provide an estimate of the participants in this clinical research?
"Affirmative, the research documentation found on clinicaltrials.gov attests to this medical trial's patient search commencing in May of 2019 and recently updated in June 2022. 72 individuals need to be recruited from two distinct locations."
Answered by AI
What criteria must participants fulfill to enter this clinical study?
"This trial is currently accepting 72 adults between the ages of 30-85 with polycythemia vera. To qualify for participation, individuals must have a ≤ 20 pack/year smoking history or quit >= 3 years ago without any COPD symptoms and normal pulmonary health; an ECOG performance status 0-2; negative pregnancy tests if applicable; highly effective contraception to reduce risk of conception until at least three months after treatment ends; ability to provide informed consent and sign approved forms conforming to federal guidelines; capability of reading and completing study questionnaires; eligible OSA screening component results which entail having sleep studies score ≥ 5 indicating OSA diagnosis"
Answered by AI
Are there any vacant slots for participants in this research study?
"As detailed on clinicaltrials.gov, this research is currently seeking participants. It was initially listed on May 15th 2019 and updated most recently in June 7th 2022."
Answered by AI
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