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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
No Placebo-Only Group
Summary
This trial studies how well a CPAP machine works in treating sleep apnea in patients with polycythemia vera or essential thrombocythemia. The CPAP machine helps keep airways open during sleep, which may improve their overall health. The trial targets patients with these conditions because they often suffer from sleep apnea.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in JAK2 V617F allele burden
Change in Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)
Other study objectives
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%
Epidermal and dermal conditions
14%
Aural disorders NEC
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Respiratory disorders NEC
7%
Gallbladder disorders
7%
Female reproductive tract infections and inflammations
7%
Upper respiratory tract disorders (excl infections)
7%
Tendon, ligament and cartilage disorders
7%
Headaches
4%
Mood disorders and disturbances NEC
4%
Diverticular disorders
4%
Muscle disorders
4%
Gastrointestinal infections
4%
Suicidal and self-injurious behaviors NEC
4%
Glucose metabolism disorders
4%
Demyelinating disorders
4%
Gastrointestinal motility
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Urinary tract signs and symptoms
4%
Depressed mood disorders and disturbances
4%
Genitourinary tract disorders NEC
4%
Procedural related injuries and complicatins NEC
4%
Ocular infections, irritations and inflammations
4%
Bone and joint injuries
4%
Anxiety disorders and symptoms
4%
Skin and subcutaneous tissue infections and infestations
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1740
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The primary treatment for Obstructive Sleep Apnea (OSA) is the Continuous Positive Airway Pressure (CPAP) machine, which works by providing pressurized air to keep the upper air passages open during sleep, preventing them from narrowing or collapsing. This is crucial for OSA patients as it helps maintain regular breathing, reduces snoring, and alleviates symptoms such as disrupted sleep, morning headaches, and daytime sleepiness.
Other treatments include oral appliances that reposition the jaw to keep the airway open and surgical options to remove or correct anatomical obstructions. These treatments aim to improve airflow and reduce the frequency of apneas and hypopneas, thereby enhancing sleep quality and reducing associated health risks.
Sleep-disordered breathing and resistant hypertension.
Sleep-disordered breathing and resistant hypertension.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,112 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,572 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.