Obesity Hypoventilation SyndromeBIOSAOSNCT03861468
Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )
A study testing Care pathway in people with Obesity Hypoventilation Syndrome and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
- What is being tested?
- Care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2019to 6 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 80 years
- Obese (BMI ≥ 30kg/m²)
- Referred by GPs to the medical analysis laboratory for usual biological assessment
- Patients with no respiratory follow-up already in place
- Patient affiliated with a social protection plan
- Bicarbonate - Concentration ≥ 27 mmol/L
- STOP-BANG score ≥ 3
- Informed written consent signed by the patient
Who cannot join
- Acute disease or recently diagnosed chronic disease (< 2 months)
- Hospitalization for respiratory, metabolic or cardiovascular event (< 2 months)
- Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis
- Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection)
- Patients already included in an interventional study (end of the study < 1 month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories
Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.
Read the detailed description
OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.
- Being tested
- Care pathway
- Keywords
- obesity hypoventilation syndrome, obstructive sleep apnea, bicarbonates, STOP-BANG
- Medical subject headings
- Obesity Hypoventilation Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathwayOther
Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual. |
| Early care | Active comparator | A different care pathway will be followed by the patients randomized to this group. They will be referred to a specialist (pneumologist) for OSA diagnosis and treatment if necessary Receives: Other: Care pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year medico-economic impact of the implementation of early care in obese patients with OSA
incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years
Measured: 24 months
Secondary outcomes (33)
Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs
The economic impact on healthcare costs from the Health Insurer's perspective will be calculated from the difference in healthcare costs between the two groups (early care vs usual care)
Measured: 3 years
To evaluate the sensitivity of the screening tool
The sensitivity will be evaluated by comparison with polysomnography
Measured: 24 months
To evaluate the specificity of the screening tool
The specificity will be evaluated by comparison with polysomnography
Measured: 24 months
To evaluate the negative Predictive Value
The negative predictive value will be evaluated by comparison with polysomnography
Measured: 24 months
To evaluate the positive predictive value of the screening tool
The positive predictive value will be evaluated by comparison with polysomnography
Measured: 24 months
Clinical impact of the early care pathway on blood pressure at 12 months
Blood pressure at home
Measured: 12 months
Clinical impact of the early care pathway on blood pressure at 24 months
Blood pressure at home
Measured: 24 months
Clinical impact of the early care pathway on quality of life at 12 months
The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.
Measured: 12 months
Clinical impact of the early care pathway on quality of life at 24 months
The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.
Measured: 24 months
Clinical impact of the early care pathway (early care) on quality of life at 12 months
Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome
Measured: 12 months
Clinical impact of the early care pathway (early care) on quality of life at 24 months
Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome
Measured: 24 months
Clinical impact of the early care pathway on pharmacological treatments at 12 months
number of pharmacological treatments
Measured: 12 months
Clinical impact of the early care pathway on pharmacological treatments at 24 months
number of pharmacological treatments
Measured: 24 months
Impact on laboratory test results (troponin) at 12 months
troponin
Measured: 12 months
Impact on laboratory test results (troponin) at 24 months
troponin
Measured: 24 months
Impact on laboratory test results (NT-proBNP) at 12 months
NT-proBNP
Measured: 12 months
Impact on laboratory test results (NT-proBNP) at 24 months
NT-proBNP
Measured: 24 months
Impact on laboratory test results on cholesterol at 12 months
cholesterol
Measured: 12 months
Impact on laboratory test results on cholesterol at 24 months
cholesterol
Measured: 24 months
Impact on laboratory test results on triglycerides at 12 months
triglycerides
Measured: 12 months
Impact on laboratory test results on triglycerides at 24 months
triglycerides
Measured: 24 months
Impact on laboratory test results on glycaemia at 12 months
glycaemia
Measured: 12 months
Impact on laboratory test results on glycaemia at 24 months
glycaemia
Measured: 24 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months
Homeostasis model assessment (HOMA)-index
Measured: 12 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months
Homeostasis model assessment (HOMA)-index
Measured: 24 months
Impact on laboratory test results on hepatic transaminases at 12 months
transaminases (ASAT, ALAT)
Measured: 12 months
Impact on laboratory test results on hepatic transaminases at 24 months
transaminases (ASAT, ALAT)
Measured: 24 months
Impact on laboratory test results on creatinine at 12 months
creatinine
Measured: 12 months
Impact on laboratory test results on creatinine at 24 months
creatinine
Measured: 24 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months
C-Reactive Protein (CRP)
Measured: 12 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months
C-Reactive Protein (CRP)
Measured: 24 months
Impact on laboratory test results on alpha2-macroglobulin at 12 months
alpha2-macroglobulin
Measured: 12 months
Impact on laboratory test results on alpha2-macroglobulin at 24 months
alpha2-macroglobulin
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start14 Sep 2019
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open, controlled, randomized clinical trial (cluster randomization)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Poitiers University Hospital, Union hospital, Toulouse, Hospital Alpes Leman, Annemasse, Hospital La Louvière, Lille, Oriade Laboratory, Vizille, Cerballiance laboratories, Lille, Oriade laboratory, Annemasse
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861468
- Sponsor's protocol ID
- 38RC17.360
- Acronym
- BIOSAOS
- Status last verified
- Jan 2023
- First submitted
- 22 Feb 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories
- ClinicalTrials.gov ID
- NCT03861468
- Acronym / sponsor ID
- BIOSAOS / 38RC17.360
- Keywords
- obesity hypoventilation syndrome, obstructive sleep apnea, bicarbonates, STOP-BANG
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Poitiers University Hospital, Union hospital, Toulouse, Hospital Alpes Leman, Annemasse, Hospital La Louvière, Lille, Oriade Laboratory, Vizille, Cerballiance laboratories, Lille, Oriade laboratory, Annemasse
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 4 Mar 2019 (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.
Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.
Detailed description
OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open, controlled, randomized clinical trial (cluster randomization)
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual. |
| Early care | Active comparator | Other: Care pathwayA different care pathway will be followed by the patients randomized to this group. They will be referred to a specialist (pneumologist) for OSA diagnosis and treatment if necessary |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged from 18 to 80 years
- Obese (BMI ≥ 30kg/m²)
- Referred by GPs to the medical analysis laboratory for usual biological assessment
- Patients with no respiratory follow-up already in place
- Patient affiliated with a social protection plan
Key exclusion criteria (5 listed)
- Acute disease or recently diagnosed chronic disease (< 2 months)
- Hospitalization for respiratory, metabolic or cardiovascular event (< 2 months)
- Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis
- Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection)
- Patients already included in an interventional study (end of the study < 1 month)
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 |
|---|---|---|
| Care pathwayScreening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary | Other | Early care |
Primary outcome
2-year medico-economic impact of the implementation of early care in obese patients with OSA
Time frame: 24 months
incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years
33 secondary outcomes
Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs
Time frame: 3 years
To evaluate the sensitivity of the screening tool
Time frame: 24 months
To evaluate the specificity of the screening tool
Time frame: 24 months
To evaluate the negative Predictive Value
Time frame: 24 months
To evaluate the positive predictive value of the screening tool
Time frame: 24 months
Clinical impact of the early care pathway on blood pressure at 12 months
Time frame: 12 months
Clinical impact of the early care pathway on blood pressure at 24 months
Time frame: 24 months
Clinical impact of the early care pathway on quality of life at 12 months
Time frame: 12 months
Clinical impact of the early care pathway on quality of life at 24 months
Time frame: 24 months
Clinical impact of the early care pathway (early care) on quality of life at 12 months
Time frame: 12 months
Clinical impact of the early care pathway (early care) on quality of life at 24 months
Time frame: 24 months
Clinical impact of the early care pathway on pharmacological treatments at 12 months
Time frame: 12 months
Clinical impact of the early care pathway on pharmacological treatments at 24 months
Time frame: 24 months
Impact on laboratory test results (troponin) at 12 months
Time frame: 12 months
Impact on laboratory test results (troponin) at 24 months
Time frame: 24 months
Impact on laboratory test results (NT-proBNP) at 12 months
Time frame: 12 months
Impact on laboratory test results (NT-proBNP) at 24 months
Time frame: 24 months
Impact on laboratory test results on cholesterol at 12 months
Time frame: 12 months
Impact on laboratory test results on cholesterol at 24 months
Time frame: 24 months
Impact on laboratory test results on triglycerides at 12 months
Time frame: 12 months
Impact on laboratory test results on triglycerides at 24 months
Time frame: 24 months
Impact on laboratory test results on glycaemia at 12 months
Time frame: 12 months
Impact on laboratory test results on glycaemia at 24 months
Time frame: 24 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months
Time frame: 12 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months
Time frame: 24 months
Impact on laboratory test results on hepatic transaminases at 12 months
Time frame: 12 months
Impact on laboratory test results on hepatic transaminases at 24 months
Time frame: 24 months
Impact on laboratory test results on creatinine at 12 months
Time frame: 12 months
Impact on laboratory test results on creatinine at 24 months
Time frame: 24 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months
Time frame: 12 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months
Time frame: 24 months
Impact on laboratory test results on alpha2-macroglobulin at 12 months
Time frame: 12 months
Impact on laboratory test results on alpha2-macroglobulin at 24 months
Time frame: 24 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 5 Jan 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, MD, PhD principal investigator
Grenoble Alpes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care pathway in people with Obesity Hypoventilation Syndrome and Obstructive Sleep Apnea, run by University Hospital, Grenoble 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 8 inclusion and 5 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 5 Jan 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. 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?
2-year medico-economic impact of the implementation of early care in obese patients with OSA (time frame: 24 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 5 Jan 2023.