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Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome

NCT05758324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-07

No results posted yet for this study

Summary

Obstructive sleep apnea syndrome (OSA) is defined by the association of clinical symptoms - drowsiness in particular - and sleep breathing disorders, objectified by measuring the apnea-hypopnea index (AHI). Apneas and hypopneas during sleep are responsible for micro-arousals and hypoxemia.

In the short term, these result in daytime sleepiness with reduced alertness, difficulty driving and carrying out tasks (increased risk of road accidents and accidents at work), memory and concentration problems. , mood disorders. These disturbances lead to an impairment of the quality of life.

In the long term, severe OSA (AHI \> 30 events/hour) increases all-cause mortality and cardiovascular morbidity.

The reference treatment is nasal ventilation by Continuous Positive Airway Pressure (CPAP). In practice, the observance and effectiveness of CPAP are limited by the sometimes difficult acceptance of cumbersome equipment, involving noise pollution and requiring the wearing of night-time equipment that some patients find difficult to bear.

The alternative treatment is represented by the mandibular advancement orthosis . Lifestyle and dietary measures are always recommended.

To date, no pharmacological treatment has demonstrated its effectiveness in OSA.

Studies have shown that the antioxidant capacity of the blood is reduced in patients with OSA. It would be secondary to the cycles of hypoxia and reoxygenation which cause a modification of the oxidative balance, leading to an increase in free radicals. It has been observed that the serum levels of trace elements and heavy metals are higher during OSA, by deterioration of the balance of these substances due to oxidative stress and inflammation.

Antioxidant therapies have reduced biomarkers of oxidative stress in apneic patients.

A new path of research is opening up with the use of antioxidants and trace elements in OSA.

To scientifically support the hypothesis of the action of these supplements based on trace metals on OSA, PRONUTRI wish to conduct a comparative, randomized, double-blind study versus placebo evaluating the effect of a specific complex of trace metals in the OSA.

Conditions

  • Apnea, Obstructive

Interventions

DIETARY_SUPPLEMENT

Nutri PNEA

4 sequences of 10 tablets (one intake)

DIETARY_SUPPLEMENT

Placebo

4 sequences of 10 tablets (one intake)

Sponsors & Collaborators

  • Clin-Experts

    collaborator INDUSTRY

  • Laboratoires Pronutri

    lead INDUSTRY

Principal Investigators

  • Jean-Louis PEPIN · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758324 on ClinicalTrials.gov