All > Essential Thrombocythemia > Polycythemia Vera

Continuous Positive Airway Pressure for Obstructive Sleep Apnea

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute/University of Utah, Salt Lake City, UTObstructive Sleep Apnea+5 MoreContinuous Positive Airway Pressure - Procedure
Eligibility
30 - 85
All Sexes
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Study Summary

This trial will study whether CPAP is an effective treatment for obstructive sleep apnea in patients with polycythemia vera or essential thrombocythemia.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Polycythemia Vera
  • JAK2 Gene Mutation
  • Essential Thrombocythemia
  • CALR Gene Mutation
  • MPL Gene Mutation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Ropeginterferon alfa-2b (P1101)
1
IONIS-TMPRSS6-LRx
1
Continuous Positive Airway Pressure

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline, after 3 months, and after 6 months on trial

Month 6
Change in JAK2 V617F allele burden
Change in Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)
Leucocytes, platelets, red cell counts, and tumor necrosis factor (TNF) analysis
Thrombotic and inflammatory marker levels for all patients
During the OSA screening
Proportion of patients with a diagnosis of obstructive sleep apnea (OSA)

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Ropeginterferon alfa-2b (P1101)
2
IONIS-TMPRSS6-LRx
1
Continuous Positive Airway Pressure

Side Effects for

Laparoscopic Gastric Banding
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%Respiratory disorders NEC
7%Tendon, ligament and cartilage disorders
7%Headaches
7%Gallbladder disorders
7%Female reproductive tract infections and inflammations
7%Upper respiratory tract disorders (excl infections)
4%Skin and subcutaneous tissue infections and infestations
4%Mood disorders and disturbances NEC
4%Ocular infections, irritations and inflammations
4%Gastrointestinal motility
4%Gastrointestinal infections
4%Bone and joint injuries
4%Urinary tract signs and symptoms
4%Coronary artery disrders
4%Anxiety disorders and symptoms
4%Suicidal and self-injurious behaviors NEC
4%Bone disorders (excl congenital and fractures)
4%Diverticular disorders
4%Medication errors
4%Procedural related injuries and complicatins NEC
4%Musculoskeletal and connective tissue disorders NEC
4%Glucose metabolism disorders
4%Muscle disorders
4%Depressed mood disorders and disturbances
4%Demyelinating disorders
4%Genitourinary tract disorders NEC
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01187771) in the Laparoscopic Gastric Banding ARM group. Side effects include: Respiratory tract infections with 32%, Drowsy driving with 21%, Injuries NEC with 18%, Epidermal and dermal conditions with 14%, Aural disorders NEC with 14%.

Trial Design

2 Treatment Groups

Cohort I (observation)
1 of 2
Cohort II: (CPAP treatment)
1 of 2

Active Control

Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Continuous Positive Airway Pressure · No Placebo Group · Phase < 1

Cohort II: (CPAP treatment)Experimental Group · 2 Interventions: Continuous Positive Airway Pressure, Questionnaire Administration · Intervention Types: Procedure, Other
Cohort I (observation)ActiveComparator Group · 2 Interventions: Patient Observation, Questionnaire Administration · Intervention Types: Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after 3 months, and after 6 months on trial

Who is running the clinical trial?

University of UtahLead Sponsor
1,008 Previous Clinical Trials
1,787,310 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,852 Total Patients Enrolled
Krishna SundarPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Eligibility Criteria

Age 30 - 85 · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a high score (3 or more) on the STOP-BANG questionnaire, which includes questions about snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender.
You have smoked less than 20 packs of cigarettes in your life or quit smoking at least 3 years ago and show no signs of lung problems.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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