NCT05758324: OLIGO-SAS

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

Status unknown NA Last updated 7 March 2023

What this trial tests

NA trial testing Nutri PNEA in Apnea, Obstructive in 42 participants. Status unknown.

Timeline

1 March 2023

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	Laboratoires Pronutri
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	42
Start date	1 March 2023
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	1 location across France

Drugs / interventions tested

• Nutri PNEA
• Placebo

Conditions studied

• Apnea, Obstructive — all drugs for Apnea, Obstructive →

Sponsor

Laboratoires Pronutri

Who can join

18 and older, any sex, with Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.