Cardiovascular Disease in Obstructive Sleep ApneaEndothSASNCT02573116
Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
A study testing scaling and root planing in people with Cardiovascular Disease in Obstructive Sleep Apnea, run by Hopital Foch at 1 site in France.
Trial summary
Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cardiovascular Disease in Obstructive Sleep Apnea
- What is being tested?
- scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2014to 6 Jun 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe OSA defined by an apnea hypopnea index > or = 30 per hour
- with or without chronic parodontitis
Who cannot join
- non equilibrated diabetes
- obesity (BMI > or = 40)
- active smoker (> 1 pack per day (20 cigarettes))
- pregnancy
- antibiotics within the preceding three months
- prophylactic antibiotherapy required for the parodontitis treatment
- acute parodontitis or all parontal pathology requiring immediate therapy
- less than 10 teeth
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.
Read the detailed description
At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.
- Being tested
- scaling and root planing
- Keywords
- obstructive sleep apnea, endothelial dysfunction, periodontitis
- Medical subject headings
- Sleep Apnea, Obstructive, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea with chronic parodontis | Experimental | patients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment Receives: Procedure: scaling and root planing |
| Obstructive sleep apnea without chronic parodontis | No intervention | patients with severe OSA treated by CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
Measured: 20 weeks
Secondary outcomes (3)
Endothelial function
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
Measured: 10 weeks
blood biomarkers
hsCRP, leptin, adiponectin, E-selectin and orosomucoid
Measured: 0, 10 and 20 weeks
Epworth Sleepiness Scale
Measured: 0, 10 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start24 Mar 2014
- Primary completion22 Dec 2016
- Study completion6 Jun 2017
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease in Obstructive Sleep ApneaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priscilla Henno, MD, Principal investigator, AP-HP, Hôpital Européen Georges Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573116
- Sponsor's protocol ID
- 2013/44
- Acronym
- EndothSAS
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2015
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02573116
- Acronym / sponsor ID
- EndothSAS / 2013/44
- Keywords
- obstructive sleep apnea, endothelial dysfunction, periodontitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 9 Oct 2015 (estimated)
- 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.
Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.
Detailed description
At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea with chronic parodontis | Experimental | Procedure: scaling and root planingpatients with severe obstructive sleep apnea (OSA) and chronic parodontis treated for OSA by continuous positive airway pressure (CPAP) and intensive periodontal treatment |
| Obstructive sleep apnea without chronic parodontis | No intervention | –patients with severe OSA treated by CPAP |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- severe OSA defined by an apnea hypopnea index > or = 30 per hour
- with or without chronic parodontitis
Key exclusion criteria (8 listed)
- non equilibrated diabetes
- obesity (BMI > or = 40)
- active smoker (> 1 pack per day (20 cigarettes))
- pregnancy
- antibiotics within the preceding three months
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 |
|---|---|---|
| scaling and root planingfull-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia | Procedure or surgery | Obstructive sleep apnea with chronic parodontis |
Primary outcome
Endothelial function
Time frame: 20 weeks
measure of Reactive Hyperemia- Peripheral Artery Tone index with Endopat
3 secondary outcomes
Endothelial function
Time frame: 10 weeks
blood biomarkers
Time frame: 0, 10 and 20 weeks
Epworth Sleepiness Scale
Time frame: 0, 10 and 20 weeks
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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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.
Priscilla Henno, MD principal investigator
AP-HP, Hôpital Européen Georges Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and root planing in people with Cardiovascular Disease in Obstructive Sleep Apnea, run by Hopital Foch 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 8 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: stopped early, as of the sponsor's last update on 3 Oct 2018. 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 stopped early (reason given: Insufficient recruitment). 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?
Endothelial function (time frame: 20 weeks). 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 3 Oct 2018.