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

NCT05758324 | Unknown

• 1 other identifier: 2022-A01340-43
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

trace elements; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Change in the number of apneas/hypopneas

  60 days

Secondary Outcomes (6)

• Change in Ventilatory Response

  60 days

• Proportion of patients with a 50% reduction in the apnea-hypopnea index

  60 days

• Proportion of patients with an apnea-hypopnea index < 30/hour

  60 days

• Proportion of patients with an apnea-hypopnea index < 15/hour

  60 days

• Change in sleep quality

  60 days

Study Arms (2)

Trace elements

EXPERIMENTAL

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.

Dietary Supplement: Nutri PNEA

Placebo

PLACEBO COMPARATOR

4 sequences of 10 tablets containing only excipients

Dietary Supplement: Placebo

Interventions

Nutri PNEA DIETARY_SUPPLEMENT

4 sequences of 10 tablets (one intake)

Trace elements

Placebo DIETARY_SUPPLEMENT

4 sequences of 10 tablets (one intake)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Pronutri: lead
• Clin-Experts: collaborator

Study Sites (1)

Laboratoire EFCR - CHU de Grenoble

Grenoble, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis PEPIN

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 7, 2023
• Study Start: March 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)