Informations générales (source: ClinicalTrials.gov)

NCT05758324 Statut inconnu
Prospective, Randomized, Double-blind, Parallel-group Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome (OLIGO-SAS)
Interventional
  • Apnée
  • Syndromes d'apnées du sommeil
  • Syndrome d'apnées obstructives du sommeil
N/A
Laboratoires Pronutri (Voir sur ClinicalTrials)
mars 2023
janvier 2024
08 mars 2025
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.

Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Laboratoire EFCR - CHU de Grenoble - Grenoble - France MARIE JOYEUX-FAURE Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- adult patient with moderate to severe sleep apnea-hypopnea syndrome confirmed by
polysomnography dating less than 3 months with an apneas/hypopneas index ≥ 15
events/h

- stable weight (5% variation of the weight at the time of the polysomnography done
within 3 months)



- patient previously treated for OSA by continuous positive airway pressure or
mandibular orthosis

- obesity (body mass index > 30 kg/m2)

- pregnant or post-pregnancy women less than 6 months old or of childbearing age
without an effective method of contraception

- respiratory, cardiac, hepatic or renal failure

- active cancer or history of cancer

- alcohol abuse

- antidepressant intake

- use of compression stockings

- intake of product or supplementation enriched with trace metals and/or trace
elements and/or mineral salts and/or vitamins.

- taking any type of psychotropic medication

- previous intake of trace elements to treat OSA