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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 weeks
Treatment ~ Varies
Follow Up ~baseline, after 3 months, and after 6 months on trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 3 months, and after 6 months on trial for reporting.

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 • NCT01187771
32%
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
~1720

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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,108 Previous Clinical Trials
1,788,411 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,732 Previous Clinical Trials
40,967,840 Total Patients Enrolled
Krishna SundarPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Continuous Positive Airway Pressure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03972943 — Phase < 1
Obstructive Sleep Apnea Research Study Groups: Cohort II: (CPAP treatment), Cohort I (observation)
Continuous Positive Airway Pressure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03972943 — Phase < 1
Obstructive Sleep Apnea Clinical Trial 2023: Continuous Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT03972943 — Phase < 1
~1 spots leftby Jun 2025