Informations générales (source: ClinicalTrials.gov)
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
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 | |||||
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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)
- 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