What side effects are associated with this type of intervention?

The most common treatment for Obstructive Sleep Apnea (OSA) is the use of a Continuous Positive Airway Pressure (CPAP) machine, which can have side effects such as nasal congestion, dry mouth, skin irritation from the mask, and discomfort. Other treatments include oral appliances, which may cause jaw discomfort, excessive salivation, or dry mouth. Pharmacologic treatments are less common and can have side effects like dizziness, diarrhea, and visual disturbances. Overall, CPAP therapy is generally well-tolerated and effective in improving sleep quality and reducing OSA symptoms.

What prior FDA approvals exist?

The primary FDA-approved treatment for obstructive sleep apnea (OSA) that is similar to the CPAP machine is the use of positive airway pressure (PAP) devices, including CPAP, BiPAP (bilevel positive airway pressure), and APAP (automatic positive airway pressure). These devices work by providing pressurized air to keep the upper air passages open during sleep, preventing airway collapse. While there are no specific drugs approved by the FDA solely for the treatment of OSA, pharmacologic agents such as modafinil and armodafinil are approved for managing excessive daytime sleepiness associated with OSA. Additionally, investigational drugs like sulthiame and dronabinol have shown some promise in early studies but are not yet approved for routine use in OSA treatment.

What other types of research exist?

Promising alternatives to CPAP for treating obstructive sleep apnea include oral appliances, such as mandibular advancement devices, which reposition the lower jaw to keep the airway open. Hypoglossal nerve stimulation, which involves an implanted device that stimulates the nerve controlling tongue movements to prevent airway collapse, is another option. Pharmacologic agents, though not yet proven to replace CPAP, are being investigated, including drugs that reduce upper airway collapsibility and cannabinoids like dronabinol. Weight loss and lifestyle interventions also show significant benefits in reducing OSA severity.

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Procedure

CPAP for Obstructive Sleep Apnea

Q: What is the mechanism of action of this treatment?

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.

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

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

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 • 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

Respiratory disorders NEC

Gallbladder disorders

Female reproductive tract infections and inflammations

Upper respiratory tract disorders (excl infections)

Tendon, ligament and cartilage disorders

Headaches

Diverticular disorders

Muscle disorders

Gastrointestinal infections

Gastrointestinal motility

Suicidal and self-injurious behaviors NEC

Mood disorders and disturbances NEC

Musculoskeletal and connective tissue disorders NEC

Glucose metabolism disorders

Demyelinating disorders

Medication errors

Bone disorders (excl congenital and fractures)

Urinary tract signs and symptoms

Anxiety disorders and symptoms

Depressed mood disorders and disturbances

Genitourinary tract disorders NEC

Procedural related injuries and complicatins NEC

Ocular infections, irritations and inflammations

Bone and joint injuries

Skin and subcutaneous tissue infections and infestations

Coronary artery disrders

100%

80%

60%

40%

20%

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

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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.