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

NCT ID: NCT05758324

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-01-31

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.

Conditions

Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Trace elements

Nutri PNEA in a single dose (4 sequences of 10 tablets). Nutri PNEA is a complex of trace elements with the status of a food supplement.

Group Type: EXPERIMENTAL

Nutri PNEA

Intervention Type: DIETARY_SUPPLEMENT

4 sequences of 10 tablets (one intake)

Placebo

4 sequences of 10 tablets containing only excipients

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

4 sequences of 10 tablets (one intake)

Interventions

Nutri PNEA

4 sequences of 10 tablets (one intake)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

4 sequences of 10 tablets (one intake)

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clin-Experts

INDUSTRY

Sponsor Role: collaborator

Laboratoires Pronutri

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis PEPIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Laboratoire EFCR - CHU de Grenoble

Grenoble, , France

Countries

France

Facility Contacts

MARIE JOYEUX-FAURE

Role: primary

Other Identifiers

2022-A01340-43

Identifier Type: -

Identifier Source: org_study_id