CLINICAL TRIAL

Treatment for Sleep Apnea, Obstructive

Waitlist Available · 18+ · All Sexes · Bologna, Italy

This study is evaluating whether a drug may help improve cognitive function in individuals with excessive daytime sleepiness.

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About the trial for Sleep Apnea, Obstructive

Eligible Conditions
Disorders of Excessive Somnolence · Sleepiness · Sleep Apnea Syndromes · Obstructive Sleep Apnea (OSA) · Apnea · Sleep Apnea, Obstructive · Excessive Daytime Somnolence

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Placebo
DRUG
Control Group 2
Solriamfetol
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have used PAP therapy regularly for at least one month before the study began, or people who have not used PAP therapy recently but have tried it for one month in the past and made at least one adjustment to try to improve the therapy, or people who have had a surgery to treat symptoms of OSA, are all eligible for the study. show original
People usually sleep for six hours or more each night. show original
People with a body mass index from 18.5 to less than 40 kg/m2 are considered to be overweight or obese. show original
methods if engaging in heterosexual intercourse Prefer and usually live a lifestyle without heterosexual intercourse (abstinent on a long-term and persistent basis), but if engaging in heterosexual intercourse, agree to use contraception/barrier methods. show original
for women at high risk for unintended pregnancy a good choice for her? Yes, a WOCBP who is using a contraceptive method that is highly effective for women at high risk for unintended pregnancy is making a good choice for herself. show original
In a position to give their consent after being fully informed. show original
People between the ages of 18 and 65 who are either male or female. show original
The individual snores loudly and has episodes of breathing cessation during sleep. show original
• Refrain from donating sperm
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to the end of double-blind treatment period (up to study day 37)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to the end of double-blind treatment period (up to study day 37)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to the end of double-blind treatment period (up to study day 37).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Sleep Apnea, Obstructive. Measurement will happen over the course of Baseline to the end of double-blind treatment period (up to study day 37).

Change from the average of the 2- and 4-hour DSST RBANS scores at Baseline (Visit 3) to the average of the 2- and 4-hour postdose DSST RBANS scores at the end of each double blind period
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
Change from the average of the 2-, 4-, 6-, and 8-hour DSST RBANS scores at Baseline to the average of the 2-, 4-, 6-, and 8-hour postdose DSST RBANS scores at the end of each double-blind treatment period
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
Change from each of the 2-, 4-, 6-, and 8-hour DSST RBANS sores at Baseline to each of the corresponding 2-, 4-, 6-, and 8-hour postdose DSST RBANS scores at the end of each double-blind treatment period
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
Change from baseline to the end of each double-blind treatment in overall score in BC-CCI
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)
BASELINE TO THE END OF DOUBLE-BLIND TREATMENT PERIOD (UP TO STUDY DAY 37)

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 is sleep apnea, obstructive?

Children who breathe through their mouth must be evaluated for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea). OSA must be diagnosed in all individuals with sleep-related breathing abnormalities or sleep disordered breathing.

Anonymous Patient Answer

What are common treatments for sleep apnea, obstructive?

CPAP and tricyclic antidepressants (TCAs) are two treatments used for sleep apnea, obstructive, often with limited evidence of benefit. If medications are being considered, one of the treatments more likely to lead to improvement is amoxicillin, which is effective for sleep apnea due to infection with pneumococcus and may be effective for sleep apnea due to a history of bacterial pneumonia or sinusitis. Evidence in support of the use of inhaled epinephrine for treatment of sleep apnea is currently insufficient to support its routine use and therefore should only be considered in patients with severe symptoms refractory to other therapies.

Anonymous Patient Answer

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

OSA, OSA and AHI occur simultaneously in some patients with OSAS, and the patients with OSAS are more anxious and compliant as compared with those with OSAS Without OSA. Patients with OSAS, even those who do not meet other criteria for OSA, have significant lower cognitive function and more severe [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea)-related complaints. OSA, OSA and AHI are more frequent in Hispanic and non-white than in white patients with OSAS. Better patient knowledge about and understanding of sleep disorders should be stressed in patients with OSAS.

Anonymous Patient Answer

Can sleep apnea, obstructive be cured?

Obstructive sleep apnea does not change post-treatment. Obstructive sleep apnea seems to lead to an increase in the probability to suffer from obstructive sleep apnea even further.

Anonymous Patient Answer

What causes sleep apnea, obstructive?

Sleep problems often start with sleep paralysis and may be caused by the buildup of a fluid in the ears. Sleep apnea may be caused by [sleep paralysis], [bruxism], or both. Other possible causes, because [bruxism] is often associated with sleep apnea, are [snoring] and [dysphonia (voice change)]. [Withpower] lets you compare clinical trial treatments to see which is most useful for a cure.

Anonymous Patient Answer

What are the signs of sleep apnea, obstructive?

A positive family history of sleep apnea is a strong sign of obstructive sleep apnea. As many as 20% of all cases of obstructive sleep apnea are undiagnosed and untreated. The effect and progression of the disease to a more serious condition (such as  hypoxia  and cardiovascular disease) is often prevented through early diagnosis and appropriate treatment.

Anonymous Patient Answer

What are the common side effects of treatment?

Common side effects of treatment with AED can include fatigue, headache, insomnia, trouble with remembering, dizziness, vomiting, diarrhea, nausea, and rash. Treating [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) with AED does not increase the risk of dementia. There are a few other conditions that can increase the risk of dementia that are common comorbidities with sleep apnea. These include diabetes, hypertension, and heart disease. However, it seems that treatment with AED does not worsen the problem of sleep apnea and sleep aids do not worsen treatment with AED.

Anonymous Patient Answer

Does treatment improve quality of life for those with sleep apnea, obstructive?

Sleep apneia patients experienced decreased sleepiness and fatigue, and a decrease in OSA-related medical comorbidities. Furthermore, the OSA group exhibited improvements in QoL, including a significant decrease in severity of sleep apnea. This suggests an additional rationale for the use of CPAP therapy.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

Clinician prescribing behavior has been changing rapidly in recent years. It can be difficult to determine how this impacts clinical trial participation. To help clinicians better evaluate the quality of evidence, some trials had to be designed with specific questions about which clinical trials should be considered for inclusion.

Anonymous Patient Answer

What is the primary cause of sleep apnea, obstructive?

A significant minority of U.S. adults have symptoms of [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) that are associated with breathing disorders. Sleepers with airflow-related obstructive sleep apnea (OSAH) accounted for 45% of the total of severe sleep apnea (defined as apnea-hypopnea episodes that result in respiratory events) in the 1999-2000 U.S. National Sleep Sleep-Disorders Sleep Epidemiology Collaboration (NSSEDSPEECHL) sleep study. More than half (58%) of people with severe sleep apnea report symptoms of airway hyperfunction (i.e.

Anonymous Patient Answer

How does treatment work?

[About 5% (25%) of U.S. adults diagnosed with obstructive sleep apnoea have severe and disabling breathing problems in sleep, and only a small proportion (4%) of them use treatment for sleep apnoea. The current study has shown that a substantial proportion of people with obstructive sleep apnoea also have severe and disabling daytime sleepiness that is a risk for traffic accidents and occupational accidents, and the treatment of obstructive sleep apnoea improved health-related quality of life and functioning in people with obstructive sleep apnoea. In some cases, the use of obstructive sleep apnoea treatment improved daytime sleepiness, fatigue, and quality of life.

Anonymous Patient Answer

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

There are a number of things that could help our [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) patients, even though [Carpenter and Carter] were not able to find a cure. The American Board of Sleep Medicine (ABMS) has developed a number of different treatments including medications and surgery for sleep apnea. However, they still do not have any kind of cure. It has been reported that there is some evidence that a number of the treatments used can help some patients but not all of them. Moreover, there is not much research being done to find a cure at all.

Anonymous Patient Answer
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