Alpha Lipoic Acid 600 MG Oral Tablet for Apnea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UBC Hospital, Vancouver, Canada
Apnea+3 More
Alpha Lipoic Acid 600 MG Oral Tablet - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients

See full description

Eligible Conditions

  • Apnea
  • Obstructive Sleep Apnea of Adult

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Alpha Lipoic Acid 600 MG Oral Tablet will improve 2 primary outcomes and 6 secondary outcomes in patients with Apnea. Measurement will happen over the course of 8 weeks.

8 weeks
Augmentation Index (AI)
Level of C reactive protein (CRP)
Plasma level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Plasma level of 8-isoprostane
Reactive hyperemia index (RHI)
Telomere length
Urinary level of 8-hydroxy-2-deoxy guanosine (8-OHdG)
Urinary level of 8-isoprostane

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Alpha Lipoic Acid
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Alpha Lipoic Acid 600 MG Oral Tablet 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 2 & 3 and have had some early promising results.

Alpha Lipoic Acid
Drug
alpha lipoic acid PO 600 mg daily for 8 weeks
Placebo
Drug
placebo PO daily for 8 weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Who is running the study

Principal Investigator
R. J.
Prof. Rachel Jen, Clinical Assistant Professor
University of British Columbia

Closest Location

UBC Hospital - Vancouver, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Medically stable adult patients between 35 and 60 years of age with moderate to severe OSA (AHI>15 events/hour by a full night in-laboratory polysomnogram or ambulatory study)
More than 9 minutes/night spent below oxygen saturation of 90%.
Subjects who have declined therapy, or who have not adhered to CPAP therapy for at least one month prior to the study recruitment .

Patient Q&A Section

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

"Approximately 1.5 million adults, mostly women, have obstructive sleep apnea while about 1.3 million have central sleep apnea. This data should help to inform practitioners of the importance of screening for sleep apnea as they are at higher risk of complications from sleep apnea, including cardio- and cerebrovascular accidents, and congestive heart failure." - Anonymous Online Contributor

Unverified Answer

What causes apnea?

"apnea may be the result of several underlying organic, neurological, or psychological mechanisms, all involving some abnormal functioning or structure of the brain. The most plausible theory is that apnea arises from insufficient neuronal discharge as a normal response to an acute change in oxygen concentration." - Anonymous Online Contributor

Unverified Answer

What are common treatments for apnea?

"When the cause of respiratory arrest is known, it is reasonable to proceed immediately for tracheal intubation, and proceed to resuscitation attempts. If CPR fails, then artificial ventilation must be instituted immediately to obtain appropriate oxygenation." - Anonymous Online Contributor

Unverified Answer

What is apnea?

"All of these patients have apnea but they were not given the appropriate diagnostic evaluations for this disorder. In these patients, apnea is a disorder in which the patient was not monitored appropriately. This lack of monitoring can easily lead to the development of an apnoeic event and consequently death in the absence of appropriate treatment." - Anonymous Online Contributor

Unverified Answer

Can apnea be cured?

"There is poor evidence that adenotonsillectomy reduces the likelihood of the occurrence of apnoeic spells in children. Tonsillectomy did not alter the rates of subsequent adenoid growth when performed according to published guidelines for the surgery of children between 2 and 4 years of age." - Anonymous Online Contributor

Unverified Answer

What are the signs of apnea?

"In neonatal intensive care unit patients, apnea has been seen in infants as young as 24 hours old. In this population, apnea signs can include a decrease in respiratory rate or oxygen saturation. In contrast to infants, apnea does not occur in healthy infants, and these infants are generally free of signs of apnea." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of apnea?

"Sleep-related respiratory disturbances may be primary in approximately one-third of children with sleep-related breathing disorders. The most common and predictable cause of apnea is an upper airway collapse during sleep and is not limited to the obstructive pathologies found in infants. The diagnosis of apnea in young children and treatment of apnea vary greatly from that of adults. Treatment of breathing abnormalities should therefore be taken into account in the management of each individual patient." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of alpha lipoic acid 600 mg oral tablet?

"The most common side effect of ALA is headache. The headache tends to resolve after the medication is stopped, and it is thought that it results from the drug's ability to scavenge reactive oxygen species (ROS). The second most common side-effect is constipation. It is recommended that if you are taking a patient medication with ALA that you do not take more than your daily dose of 1200 mg ALA at a time." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving alpha lipoic acid 600 mg oral tablet?

"The treatment of LA in patients diagnosed with T1-4N 0-1 M0 disease was well tolerated. It was shown that LA (600 mg/day) is ineffective for treatment for patients with lung-limited or head-and-neck cancer and for those who have not had successful treatment prior to the inclusion in the study. In the same study, the overall survival was prolonged by a median of 3 months. The most frequent toxicity was leukopenia, which occurred in 27 % of patients, but was generally mild. The most common site of toxicity was in the hematologic system, primarily leukopenia and thrombocytopaenia, which occurred in 14 % of patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in alpha lipoic acid 600 mg oral tablet for therapeutic use?

"ALA 600 mg oral tablet is a well tolerated, well tolerated and effective treatment for MELAS syndrome. There is a need to determine the long term efficacy of the treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for apnea?

"Most clinical Trialists have no information regarding the comorbidities of patients presenting to trials to be treated for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea). This information may influence an investigator's perception of a patient's willingness to participate in a sleep disorder treatment trial and may potentially influence clinical Trialists' decisions regarding the patients they select for inclusion in a clinical trial." - Anonymous Online Contributor

Unverified Answer

What does alpha lipoic acid 600 mg oral tablet usually treat?

"Although it is used in a broad range of conditions, including rheumatoid arthritis and osteoarthritis, this review showed no evidence for any benefit of L-α lipoic acid 600 mg for controlling the pain or improving the function, mobility, or comfort in these conditions. This review also found no evidence to support it being useful in patients with rheumatoid arthritis associated with osteoarthritis." - 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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