CLINICAL TRIAL

Acute Intermittent Hypoxia for Oppenheim Disease

Recruiting · 18+ · All Sexes · Gainesville, FL

This study is evaluating whether a single session of breathing in low oxygen may help people with ALS.

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About the trial for Oppenheim Disease

Eligible Conditions
Neuromuscular Diseases · Amyotrophic Lateral Sclerosis · Hypoxia · Motor Neuron Disease · Amyotrophic Lateral Sclerosis (ALS)

Treatment Groups

This trial involves 2 different treatments. Acute Intermittent Hypoxia is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Sham Acute Intermittent Hypoxia
OTHER
+
Acute Intermittent Hypoxia
OTHER
Experimental Group 2
Sham Acute Intermittent Hypoxia
OTHER
+
Acute Intermittent Hypoxia
OTHER

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
a healthy adult
clinical diagnosis of ALS
baseline FVC >60% predicted for age, sex and height.
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Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 Hours
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 Hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 Hours.
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 Acute Intermittent Hypoxia will improve 2 primary outcomes and 3 secondary outcomes in patients with Oppenheim Disease. Measurement will happen over the course of 3 Hours.

Ventilatory Drive
3 HOURS
Respiratory drive will be estimated with pressure generation against a transiently occluded airway in the first 0.1 sec of inspiration. Five measurements will be conducted, with 5-15 un-occluded breaths between each P0.1 measurement. This validated test is resistant to learning or sensory bias and reflects unaltered neuromuscular effort.
3 HOURS
Surface electromyography (EMG)
3 HOURS
Surface EMGs of the respiratory muscles (up to six muscles, bilaterally: scalene, sternocleidomastoid, 2nd parasternal, 5th external intercostal, 8th external intercostal, and diaphragm) will be recorded during the test session. The root mean square (RMS) of each muscle will be averaged.
3 HOURS
Maximal Voluntary Grip Force
3 HOURS
Maximal static voluntary handgrip contractions will be evaluated in a seated position with the arm at the side and elbow flexed to 90 degrees. The test will be repeated until 3 measurements are obtained with <10% variability, and a minimum 15-second rest between measurements.
3 HOURS
Minute Ventilation
3 HOURS
A pneumotachograph and pressure transducer connected to the face mask will record breath-by-breath flow, volume, mouth pressure, and breathing rate. After achieving a stable tidal volume, 5 minutes of tidal breathing will be recorded.
3 HOURS
Maximal Respiratory Pressures
3 HOURS
Maximal voluntary static contractions of the inspiratory or expiratory muscles against a closed valve, measured at the mouth. Sniff nasal inspiratory pressure measures inspiratory force generation at the nose.The test will be repeated until 3 measurements are obtained within 10% variability; a minimum 20-second rest will be provided between hypoxic episodes.
3 HOURS

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 are the signs of oppenheim disease?

This patient's symptoms and MR imaging/MRI findings are highly suggestive of the disease, but the lack of specific pathology on surgical excision of his abdominal tumors eliminates them from the differential diagnosis. However, the presence of the aforementioned symptoms without the surgical findings of focal adenoma should still raise suspicion for this entity.

Anonymous Patient Answer

What is oppenheim disease?

Opd: Oppenheim Disease, a rare and asymptomatic disorder caused by a mutated human gene. Patients have a high tendency to develop malignancies, such as colon, hepatic, pancreatic, and [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer)s, but they carry no predisposition to develop such cancers. Because, to date, no specific screening tests for oppenheim disease are available and the disease is not curable; it should be considered when a patient with unexplained and unexplained hemorrhage from the skin, mucosal membranes or uterus presents.

Anonymous Patient Answer

What are common treatments for oppenheim disease?

The management of occipital lesions is a major and challenging area for neurological surgeons. The treatment of the mass and the underlying cause is very important, both radiologically and/or therapeutically. This is based on the general principles as well as the specific lesions and their position.

Anonymous Patient Answer

How many people get oppenheim disease a year in the United States?

Despite our increasing incidence of this new disorder, there appears to be a continuing decline in the number of affected individuals since the 1960s. The age at symptom onset is increasing with the exception of the first decade of life, suggesting a probable increased risk of subsequent development of Oppenheim syndrome as a result of autoimmune and inflammatory diseases that are becoming more prevalent in the aging global population. To increase our understanding of this new disease, its epidemiologic features, and the management of patients with Oppenheim syndrome, a national database of cases should be maintained, similar to a registry of other autoimmune disorders. Further study should involve the clinical presentation and medical management of all patients diagnosed with Oppenheim syndrome.

Anonymous Patient Answer

Can oppenheim disease be cured?

The prognosis for the patient's condition after treatment must be assessed following every follow-up examination. In order to make a rational decision, the patient's life expectancy should be weighed against the risk of recurrence.

Anonymous Patient Answer

What causes oppenheim disease?

As in other cases of optic atrophy, it appears that the onset of a lesion within the optic nerve results in the rapid progress towards optic retinal atrophy. The presence of a posterior macular lesion in the early stages of the disease suggests that the lesion lies deep to the peripapillary retinal nerve.

Anonymous Patient Answer

What is the latest research for oppenheim disease?

The last two years have seen major advancements in the care of patients with oppenheim disease. The introduction of new clinical trials have led to the development of more accurate and effective treatment options for patients with this rare disease.

Anonymous Patient Answer

Has acute intermittent hypoxia proven to be more effective than a placebo?

In this randomized controlled study, AIH given every 2 min for 50 min was more effective in improving exercise tolerance and heart rate recovery in patients with cardiomyopathies, especially those with hypoxemia, than a placebo.

Anonymous Patient Answer

Does acute intermittent hypoxia improve quality of life for those with oppenheim disease?

AIH improved QOL in some but not all patients with oppenheim disease. Given the risk of decompression sickness, patients should not be exposed to the underwater environment until treatment is successful.

Anonymous Patient Answer

Is acute intermittent hypoxia safe for people?

Moderate exercise for 5 hours a day for the 6 days of acute hypoxia is as safe as normobaric hypoxia and as effective as long-term use of Oxygen therapy for those living in Antarctica with respiratory disease, regardless of initial training. Exercise, even with oxygen and in harsh conditions should be the first-line treatment for hypoxia in cold, oxygen-rich environments.

Anonymous Patient Answer

What is the primary cause of oppenheim disease?

The primary cause of this syndrome is a T-cell defect, and it appears that CD4+ T-cells are depleted from peripheral blood before it is seen in the reticular fibers of the lymphoid follicles.

Anonymous Patient Answer

Is acute intermittent hypoxia typically used in combination with any other treatments?

At present, there is insufficient information on the use of AIH with other treatment modalities. In this review, there were no conclusive findings regarding the use of AIH with other treatments. More studies are needed to verify the usefulness of AIH in the management of COPD; however, if AIH has positive effects as shown in the above two case series, there is considerable potential for improving outcomes in COPD patients.

Anonymous Patient Answer
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