Clinical trial NCT05758324: Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apnea, Obstructive
Keywords: trace elements
obstructive sleep apnea
Lead sponsor: Laboratoires Pronutri
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
First posted: 2023-03-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the number of apneas/hypopneas
timeFrame: 60 days
Secondary outcomes:
measure: Change in Ventilatory Response
timeFrame: 60 days
measure: Proportion of patients with a 50% reduction in the apnea-hypopnea index
timeFrame: 60 days
measure: Proportion of patients with an apnea-hypopnea index < 30/hour
timeFrame: 60 days
measure: Proportion of patients with an apnea-hypopnea index < 15/hour
timeFrame: 60 days
measure: Change in sleep quality
timeFrame: 60 days
measure: Change in sleepiness
timeFrame: 60 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Laboratoire EFCR - CHU de Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN
role: PRINCIPAL_INVESTIGATOR
References: