Obstructive Sleep Apnea SyndromeDYNAMICNCT04947410
Intestinal Dysbiosis During Obstructive Sleep Apnea Syndrome
A study testing CPAP or nasal dilators in people with Obstructive Sleep Apnea Syndrome and Gut Microbiota, run by University Hospital, Grenoble.
Trial summary
Obstructive Sleep Apnea Syndrome (OSA) is one of the most common chronic diseases and is associated with prognostic cardiovascular and metabolic co-morbidities. OSAS is the recurrence of complete (apnea) or partial (hypopnea) collapse of the upper airway during sleep resulting in sleep fragmentation and chronic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Gut Microbiota
- What is being tested?
- CPAP or nasal dilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2021to Nov 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-SAOS Group :
- Men or women aged 18 to 70
- Subject without any OSAS
- Subject with Body Mass Index < 30 kg/m2
- Subject who has given their free and informed consent in writing
- Subject affiliated to the French social security system (or equivalent)
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- SAOS Group :
- Men or women aged 18 to 70
- Subject with OSAS (Apnea-hypopnea index > 30/hour)
- Patient with CPAP indication and untreated at baseline
- Subject with Body Mass Index < 30 kg/m2
- Effective contraception for women of childbearing age (progestational or estrogen-progestin hormonal contraceptives (pill, ring, transdermal patch), intrauterine devices or definitive sterilization)
- Subject who has given their free and informed consent in writing
- Subject affiliated to the French social security system (or equivalent)
Who cannot join
- Patient with resistant hypertension (PA ≥ 140/90 mmHg despite taking at least 3 drugs of different therapeutic classes at near maximal dose, including a diuretic)
- Infection, progressive neoplasia, unstable cardiovascular pathologies, metabolic or intestinal pathologies
- Taking of pre/probiotics and/or antibiotics in the 6 months prior to inclusion
- Major sleepiness in at-risk populations for whom the introduction of treatment by CPAP equipment is mandatory and rapid (truck drivers, crane operators ...) according to the investigator
- Patient with major desaturations during its polysomnographic diagnostic recording (≥ 2h with O2 saturation <90% on total sleep time)
- Patient with high daytime sleepiness (Epworth score > 15)
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- Contraindication to the implementation of a CPAP treatment for the SAOS group
- Contraindication to perform a subcutaneous biopsy (subject with hypersensitivity to a known local anaesthetic, abdominal skin lesion ...)
- Drastic diet (vegetarian, vegan, pescetarian), food allergies
- Subject referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, mother who is breast-feeding, person deprived of liberty by judicial or administrative decision, legally protected person)
- Subject being in an exclusion period of another study or ongoing participation in a drug study
- Patient likely, in the opinion of the investigator, not to be cooperative or respectful of the obligations inherent to participation in the study
About this study
Official title: Intestinal Dysbiosis During Obstructive Sleep Apnea Syndrome : Impact of Continuous Positive Airway Pressure (CPAP) - A Randomized Controlled Trial Versus Nasal Dilators
Obstructive Sleep Apnea Syndrome (OSA) is one of the most common chronic diseases and is associated with prognostic cardiovascular and metabolic co-morbidities. OSAS is the recurrence of complete (apnea) or partial (hypopnea) collapse of the upper airway during sleep resulting in sleep fragmentation and chronic intermittent hypoxia (ICH) which are the major determinants of cardiovascular and metabolic complications including type 2 diabetes, obesity and non-alcoholic fatty liver. These comorbidities are associated with a change in intestinal microbial ecology. In most cases, there is a reduction in bacterial genetic diversity and more or less specific signatures of cardiovascular and metabolic diseases, making it possible to envisage personalized and innovative therapeutic treatments. In animals exposed to intermittent hypoxia, there is local hypoxia that increases intestinal permeability, produces a reduction in microbiota diversity and favors microbial species that are at the origin of pro-inflammatory factors. Continuous Positive Airway Pressure (CPAP) is the standard treatment for OSA. Its effect on the intestinal microbiota has not yet been evaluated.
Read the detailed description
Background :
Obstructive Sleep Apnea Syndrome (OSAS) is one of the most common chronic diseases associated with cardiovascular and metabolic comorbidities (high blood pressure, type 2 diabetes, obesity and non-alcoholic fatty liver disease) that make it a prognosis.
These comorbidities are associated with a change in intestinal microbial ecology. In most cases, there is a reduction in bacterial genetic diversity and more or less specific signatures of cardiovascular and metabolic diseases which make it possible to envisage personalized and innovative therapeutic treatments.
In animals exposed to intermittent hypoxia, there is a local hypoxia that increases intestinal permeability, produces a reduction in microbial diversity, and favors microbial species that cause the secretion of pro-inflammatory factors.
Continuous Positive Airway Pressure (CPAP) is the gold standard for OSAS treatment. Its effect on the gut microbiota has never been evaluated.
The data will be totally original in the field. The impact of this study can be major in allowing to propose pre/probiotics or drug treatments modulating intestinal dysbiosis during OSAS, combined or not with CPAP.
Objective:
The principal objective of the study is to compare gut microbiota changes (diversity and composition : relative abundance of different phyla, genera, families, alpha and beta diversity...) after 3 months of effective CPAP versus 3 months of placebo (nasal dilators), in patients with Obstructive Sleep Apnea Syndrome.
The second objectives
Methods :
OSAS patients (with AHI > 30 / hour) will be screened in EFCR Service, Pneumology Department or Sleep Laboratory and proposed the study. If eligible they will be then followed over 3 months with 2 visits (inclusion visit at J0 and follow-up visit at 3 months). After the inclusion visit (J0) OSAS patients will be randomized for their treatment into "CPAP group" (effective CPAP treatment) or "nasal dilators group" (placebo treatment) for 3 months.
The same assessments will be carried out at J0 and 3 months.
Healthy volunteers (with no OSAS) will be the control group. They will be recruited by ad. They will carry out the assessments of inclusion visit (J0) only and compared then to the group of OSAS patients.
- Conditions
- Obstructive Sleep Apnea Syndrome, Gut Microbiota
- Being tested
- CPAP or nasal dilators
- Keywords
- intermittent hypoxia, intestinal dysbiosis
- 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.
CPAP or nasal dilatorsDevice
CPAP = active comparator nasal dilators = placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| OSAS Patients treated with CPAP | Active comparator | Patients with OSAS will have 1 in 2 chance of being randomized into "CPAP group" Receives: Device: CPAP or nasal dilators |
| OSAS Patients treated with nasal dilators | Sham comparator | Patients with OSAS will have 1 in 2 chance of being randomized into "nasal dilators group" Receives: Device: CPAP or nasal dilators |
| Non OSAS Patients | No intervention | Non OSAS Patients will be the parallel control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversity and composition of the microbiota (relative abundance of different phyla, genera, families, alpha (intra-sample) and beta (inter-sample) diversity ...)
This analysis will compare changes in intestinal microbiota after 3 months of effective CPAP versus 3 months of placebo CPAP (sham-CPAP )
Measured: 3 months
Secondary outcomes (4)
Comparison of the intestinal microbiota between non-OSAS subjects and OSAS patients (before treatment with CPAP or nasal dilators)
Comparison of the diversity and composition of the microbiota (relative abundance of different phyla, genera, families, etc.) between the two groups (OSAS and non-OSAS).
Measured: At inclusion visit (V1)
Correlation between changes in arterial blood pressure and microbiota changes between OSAS and non-OSAS, and then between CPAP and nasal dilators, after 3 months of treatment only for OSAS patients
Correlation between mean, systolic and diastolic 24 hours (day and night) arterial pressures, measured by 24-hours ambulatory recording, and modifications of the microbiota by OSAS and then by CPAP or nasal dilators
Measured: 3 months
Correlation between changes in lipid and carbohydrate profiles and changes in microbiota between OSAS patients and non-OSAS subjects, then between CPAP and nasal dilators groups after 3 months of treatment
Correlation between changes in fasting blood glucose, glycated hemoglobin (HbA1c), total cholesterol, HDL-Cholesterol, LDL-Cholesterol, triglycerides and modifications of the microbiota by OSAS and then by CPAP or nasal dilators
Measured: 3 months
Comparison of markers of inflammation, senescence and remodeling of adipose tissue between OSAS and non-OSAS, and then between CPAP and nasal dilators after 3 months of treatment
Senescence markers, adipose RNA, cytokines, immunophenotyping of macrophages
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start23 Nov 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Model description
- 2 interventional groups (15 OSAS patients into "CPAP group" versus 15 OSAS patients into "nasal dilators group") are evaluated in parallel against a control group (15 Non-OSAS Patients)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, PhD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947410
- Sponsor's protocol ID
- 38RC19.057
- Acronym
- DYNAMIC
- Status last verified
- Apr 2023
- First submitted
- 23 Jun 2021
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Dysbiosis During Obstructive Sleep Apnea Syndrome : Impact of Continuous Positive Airway Pressure (CPAP) - A Randomized Controlled Trial Versus Nasal Dilators
- ClinicalTrials.gov ID
- NCT04947410
- Acronym / sponsor ID
- DYNAMIC / 38RC19.057
- Conditions
- Obstructive Sleep Apnea Syndrome, Gut Microbiota
- Keywords
- intermittent hypoxia, intestinal dysbiosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment difficulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 Nov 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 1 Jul 2021 (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 one of the most common chronic diseases and is associated with prognostic cardiovascular and metabolic co-morbidities. OSAS is the recurrence of complete (apnea) or partial (hypopnea) collapse of the upper airway during sleep resulting in sleep fragmentation and chronic intermittent hypoxia (ICH) which are the major determinants of cardiovascular and metabolic complications including type 2 diabetes, obesity and non-alcoholic fatty liver. These comorbidities are associated with a change in intestinal microbial ecology. In most cases, there is a reduction in bacterial genetic diversity and more or less specific signatures of cardiovascular and metabolic diseases, making it possible to envisage personalized and innovative therapeutic treatments. In animals exposed to intermittent hypoxia, there is local hypoxia that increases intestinal permeability, produces a reduction in microbiota diversity and favors microbial species that are at the origin of pro-inflammatory factors. Continuous Positive Airway Pressure (CPAP) is the standard treatment for OSA. Its effect on the intestinal microbiota has not yet been evaluated.
Detailed description
Background :
Obstructive Sleep Apnea Syndrome (OSAS) is one of the most common chronic diseases associated with cardiovascular and metabolic comorbidities (high blood pressure, type 2 diabetes, obesity and non-alcoholic fatty liver disease) that make it a prognosis.
These comorbidities are associated with a change in intestinal microbial ecology. In most cases, there is a reduction in bacterial genetic diversity and more or less specific signatures of cardiovascular and metabolic diseases which make it possible to envisage personalized and innovative therapeutic treatments.
In animals exposed to intermittent hypoxia, there is a local hypoxia that increases intestinal permeability, produces a reduction in microbial diversity, and favors microbial species that cause the secretion of pro-inflammatory factors.
Continuous Positive Airway Pressure (CPAP) is the gold standard for OSAS treatment. Its effect on the gut microbiota has never been evaluated.
The data will be totally original in the field. The impact of this study can be major in allowing to propose pre/probiotics or drug treatments modulating intestinal dysbiosis during OSAS, combined or not with CPAP.
Objective:
The principal objective of the study is to compare gut microbiota changes (diversity and composition : relative abundance of different phyla, genera, families, alpha and beta diversity...) after 3 months of effective CPAP versus 3 months of placebo (nasal dilators), in patients with Obstructive Sleep Apnea Syndrome.
The second objectives
Methods :
OSAS patients (with AHI > 30 / hour) will be screened in EFCR Service, Pneumology Department or Sleep Laboratory and proposed the study. If eligible they will be then followed over 3 months with 2 visits (inclusion visit at J0 and follow-up visit at 3 months). After the inclusion visit (J0) OSAS patients will be randomized for their treatment into "CPAP group" (effective CPAP treatment) or "nasal dilators group" (placebo treatment) for 3 months.
The same assessments will be carried out at J0 and 3 months.
Healthy volunteers (with no OSAS) will be the control group. They will be recruited by ad. They will carry out the assessments of inclusion visit (J0) only and compared then to the group of OSAS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2 interventional groups (15 OSAS patients into "CPAP group" versus 15 OSAS patients into "nasal dilators group") are evaluated in parallel against a control group (15 Non-OSAS Patients)
| Arm | Type | Receives |
|---|---|---|
| OSAS Patients treated with CPAP | Active comparator | Device: CPAP or nasal dilatorsPatients with OSAS will have 1 in 2 chance of being randomized into "CPAP group" |
| OSAS Patients treated with nasal dilators | Sham comparator | Device: CPAP or nasal dilatorsPatients with OSAS will have 1 in 2 chance of being randomized into "nasal dilators group" |
| Non OSAS Patients | No intervention | –Non OSAS Patients will be the parallel control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Men or women aged 18 to 70
- Subject without any OSAS
- Subject with Body Mass Index < 30 kg/m2
- Subject who has given their free and informed consent in writing
- Subject affiliated to the French social security system (or equivalent)
Key exclusion criteria (12 listed)
- Patient with resistant hypertension (PA ≥ 140/90 mmHg despite taking at least 3 drugs of different therapeutic classes at near maximal dose, including a diuretic)
- Infection, progressive neoplasia, unstable cardiovascular pathologies, metabolic or intestinal pathologies
- Taking of pre/probiotics and/or antibiotics in the 6 months prior to inclusion
- Major sleepiness in at-risk populations for whom the introduction of treatment by CPAP equipment is mandatory and rapid (truck drivers, crane operators ...) according to the investigator
- Patient with major desaturations during its polysomnographic diagnostic recording (≥ 2h with O2 saturation <90% on total sleep time)
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 |
|---|---|---|
| CPAP or nasal dilatorsCPAP = active comparator nasal dilators = placebo comparator | Device | OSAS Patients treated with CPAP, OSAS Patients treated with nasal dilators |
Primary outcome
Diversity and composition of the microbiota (relative abundance of different phyla, genera, families, alpha (intra-sample) and beta (inter-sample) diversity ...)
Time frame: 3 months
This analysis will compare changes in intestinal microbiota after 3 months of effective CPAP versus 3 months of placebo CPAP (sham-CPAP )
4 secondary outcomes
Comparison of the intestinal microbiota between non-OSAS subjects and OSAS patients (before treatment with CPAP or nasal dilators)
Time frame: At inclusion visit (V1)
Correlation between changes in arterial blood pressure and microbiota changes between OSAS and non-OSAS, and then between CPAP and nasal dilators, after 3 months of treatment only for OSAS patients
Time frame: 3 months
Correlation between changes in lipid and carbohydrate profiles and changes in microbiota between OSAS patients and non-OSAS subjects, then between CPAP and nasal dilators groups after 3 months of treatment
Time frame: 3 months
Comparison of markers of inflammation, senescence and remodeling of adipose tissue between OSAS and non-OSAS, and then between CPAP and nasal dilators after 3 months of treatment
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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, PhD principal investigator
University Grenoble Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CPAP or nasal dilators in people with Obstructive Sleep Apnea Syndrome and Gut Microbiota, run by University Hospital, Grenoble.
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 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Diversity and composition of the microbiota (relative abundance of different phyla, genera, families, alpha (intra-sample) and beta (inter-sample) diversity ...) (time frame: 3 months). 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 24 Apr 2023.