Ibuprofen for Sleep Apnea, Obstructive

Phase-Based Estimates
2
Effectiveness
3
Safety
McMaster University Medical Centre, Hamilton, Canada
Sleep Apnea, Obstructive+3 More
Ibuprofen - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Sleep Apnea, Obstructive

Study Summary

This study is evaluating whether morphine or ibuprofen is safer and more effective than codeine for pain control in children with obstructive sleep apnea.

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Eligible Conditions

  • Sleep Apnea, Obstructive
  • Apnea
  • Sleep Apnea Syndromes
  • Pediatric Obstructive Sleep Apnea Syndrome

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Ibuprofen will improve 1 primary outcome and 2 secondary outcomes in patients with Sleep Apnea, Obstructive. Measurement will happen over the course of 1.5 years.

1.5 years
Effectiveness
Risk Factors
Safety

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Morphine

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ibuprofen is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Morphine
Drug
Receives morphine for post-surgical pain
Ibuprofen
Drug
Receives ibuprofen for post-surgical pain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
FDA approved
Ibuprofen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1.5 years for reporting.

Who is running the study

Principal Investigator
D. S.
Doron Sommer, MD
Hamilton Health Sciences Corporation

Closest Location

McMaster University Medical Centre - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
OSAS is a sleep disorder that is diagnosed with a sleep study. show original
The patient is scheduled to have a tonsillectomy and possibly an adenoidectomy at MUMC. show original
between the ages of 1-10years

Patient Q&A Section

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

What causes sleep apnea, obstructive?

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This is a review of the current understanding of the causes of sleep apnea, obstructive. It is a difficult and sometimes fatal disease and a discussion of what the treatment is and whether or not it is a good medical management.

Unverified Answer

What are common treatments for sleep apnea, obstructive?

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The most common treatment for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea), obstructive, in males is a nasal continuous positive airway pressure (CPAP) device (also called a nasal positive airway pressure monitor), which attaches to the nose on the inside forehead and connects to a patient's breathing system via tubing implanted from the nose to the patient's airway so that air is breathed automatically. Treatment is typically prescribed for sleep apnea for patients with chronic sleep apnea who do not benefit from or cannot tolerate continuous positive airway pressure (CPAP) therapy. The nasal CPAP may decrease daytime sleepiness and fatigue, as well as improve quality of life and the overall sleep architecture of a person with sleep apnea.

Unverified Answer

What is sleep apnea, obstructive?

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Sleep apnea, obstructive is characterized primarily by recurrent episodes of obstructive breathing during sleep. The episodes of mild to moderate hypopnea with a decrease in respiratory effort during sleep are the most predominant abnormalities. Oxyhemoglobin desaturation is the major contributing factor that leads to excessive daytime sleepiness and other health problems resulting from the sleep-disordered breathing syndrome. In addition, hypopnea with a reduction of baseline airway resistance, such as that found in sleep apnea, obstructive, is the underlying pathological mechanism or mechanism of the occurrence of central sleep apnea, which includes central apnea, central sleep apnea with hypopnea, and obstructive central sleep apnea.

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Can sleep apnea, obstructive be cured?

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If sleep apnea is a trigger in a patient's breathing issues, then CPAP has been shown to be effective in reducing severity of obstructive sleep apnea symptoms.

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How many people get sleep apnea, obstructive a year in the United States?

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About 0.9 million people are diagnosed with sleep apnea, obstructive in the Unites States a year. There is a wide variability in the prevalence and severity of sleep apnea in the USA with estimates varying between 0.5 and 2.5 million. The variation in prevalence estimates reflects differences in inclusion criteria and cut thresholds used in the different studies.

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What are the signs of sleep apnea, obstructive?

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Symptoms of obstructive sleep apnoea typically present themselves when people are tired and should include excessive daytime sleepiness and night-time awakening due to sleepiness, restless legs, excessive daytime sleepiness, difficulty concentrating, and heavy daytime fatigue. Moreover, a positive airway resistance index should be performed in each patient to diagnose sleep apnoea.

Unverified Answer

What is the latest research for sleep apnea, obstructive?

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sleep apnea causes significant health complications. There is the need for further study on sleep apnea. There are a number of treatments available both OSA related and non OSA related treatments. As more data becomes available, we will eventually be able to establish more precise guidelines regarding the management of sleep apnea.

Unverified Answer

Has ibuprofen proven to be more effective than a placebo?

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In these well-trained patients with mild to moderate OSA, ibuprofen was significantly more effective in reducing the AHI and the number of OSA episodes during daytime sleep than a placebo.

Unverified Answer

Who should consider clinical trials for sleep apnea, obstructive?

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Subjects who are at higher risk for a poor clinical outcome should be evaluated to gain a full picture of prognosis before participation in a phase 3 trial.

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What is the primary cause of sleep apnea, obstructive?

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Sleep-disordered breathing is the most common sleep disorder in children, so evaluating for sleep apnea is important. Obesity and airway resistance are the other leading causes of sleep apnea. A combination of the above factors may cause the syndrome.

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Have there been any new discoveries for treating sleep apnea, obstructive?

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There are many new medicines, devices, and techniques that clinicians can use to control sleep apnea. Although there has been research on the new treatments for sleep apnea, it has been slow to show the effectiveness of the therapies on quality of life and survival. Until the results from the studies on new treatments for sleep apnea become more convincing, there are no obvious therapeutic recommendations for patients with obstructive sleep apnea as of 2018. Sleep Apnea – Obstructive.

Unverified Answer

Have there been other clinical trials involving ibuprofen?

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It remains to be seen how ibuprofen will be used in patients with obstructive sleep apnea. However, studies have reported positive effects in this population. ClinicalTrials.gov, National Institutes of Health [http://clinicaltrials.gov/ct2/show/NCT00257914?term=ibuprofen&selector=ibuprofen&search=yes&rank=10&site=&cnnLinkup] (NCT00257914) and the FDA's (NCT00382810) have shown positive results thus far from ibuprofen.

Unverified Answer
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