Apnea, ObstructiveOLIGO-SASNCT05758324
Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome
A study testing Nutri PNEA in people with Apnea, Obstructive, run by Laboratoires Pronutri at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- Nutri PNEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratoire EFCR - CHU de Grenoble
Grenoble
MARIE JOYEUX-FAURE
Jean-Louis PEPIN, PhD
About this study
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
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.
Read more
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
- Being tested
- Nutri PNEA, Placebo
- Keywords
- trace elements, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri PNEADietary supplement
4 sequences of 10 tablets (one intake)
PlaceboDietary supplement
4 sequences of 10 tablets (one intake)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Nutri PNEA |
| Placebo | Placebo comparator | 4 sequences of 10 tablets containing only excipients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of apneas/hypopneas
Measured: 60 days
Secondary outcomes (6)
Change in Ventilatory Response
Change in Ventilatory Response assessed by tests of Ventilatory Response to Carbon Dioxide (CO2)
Measured: 60 days
Proportion of patients with a 50% reduction in the apnea-hypopnea index
AHI is used to diagnose obstructive sleep apnea by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.
AHI defines severity as well, the index is:
Mild, between 5 and 15 per hour Moderate, between 15 and 30 per hour Severe, over than 30 per hour
Measured: 60 days
Proportion of patients with an apnea-hypopnea index < 30/hour
AHI is used to diagnose obstructive sleep apnea by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.
AHI defines severity as well, the index is:
Mild, between 5 and 15 per hour Moderate, between 15 and 30 per hour Severe, over than 30 per hour
Measured: 60 days
Proportion of patients with an apnea-hypopnea index < 15/hour
AHI is used to diagnose obstructive sleep apnea by counting respiratory events. An index greater than 5 per hour defines a ventilatory disorder.
AHI defines severity as well, the index is:
Mild, between 5 and 15 per hour Moderate, between 15 and 30 per hour Severe, over than 30 per hour
Measured: 60 days
Change in sleep quality
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire. This will be used to measure sleep quality over the last 60 days.The self-related questions include the assessment of seven different sleep domains : sleep quality, sleep latency , sleep duration , habitual sleep efficiency, sleep disturbances , use of sleeping medications , and daytime dysfunction .The seven components scores are then added to yield a global PSQI score in the range of zero to 21. The higher the score, the worse the sleep quality. A global score greater than five is diagnostic of poor sleep quality.
Measured: 60 days
Change in sleepiness
Sleepiness will be assessed by the Epworth Sleepiness Scale (ESS).It will be used to measure daytime sleepiness .It can determine the chance of falling asleep in 8 different circumstances. ESS score can range from 0 to 24. A global score greater than ten is diagnostic of excessive daytime sleepiness .
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Pronutri
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758324
- Sponsor's protocol ID
- 2022-A01340-43
- Acronym
- OLIGO-SAS
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05758324
- Acronym / sponsor ID
- OLIGO-SAS / 2022-A01340-43
- Conditions
- Apnea, Obstructive
- Keywords
- trace elements, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Laboratoires PronutriIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trace elements | Experimental | Dietary Supplement: Nutri PNEANutri 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 sequences of 10 tablets containing only excipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutri PNEA4 sequences of 10 tablets (one intake) | Dietary supplement | Trace elements |
| Placebo4 sequences of 10 tablets (one intake) | Dietary supplement | Placebo |
Primary outcome
Change in the number of apneas/hypopneas
Time frame: 60 days
6 secondary outcomes
Change in Ventilatory Response
Time frame: 60 days
Proportion of patients with a 50% reduction in the apnea-hypopnea index
Time frame: 60 days
Proportion of patients with an apnea-hypopnea index < 30/hour
Time frame: 60 days
Proportion of patients with an apnea-hypopnea index < 15/hour
Time frame: 60 days
Change in sleep quality
Time frame: 60 days
Change in sleepiness
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri PNEA in people with Apnea, Obstructive, run by Laboratoires Pronutri at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of apneas/hypopneas (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.