Obstructive Sleep Apnea SyndromeTHERMA-SASNCT02559427
SPA Therapy in the Treatment of Sleep Apnea Syndrome
A study testing 3-week immediate SPA treatment and 3-week late SPA treatment in people with Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency, run by Association Francaise pour la Recherche Thermale at 9 sites in France.
Trial summary
The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Chronic Venous Insufficiency
- What is being tested?
- 3-week immediate SPA treatment and 3-week late SPA treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 9 sitesFrance
- Study dates
- Oct 2016to Mar 2019
- 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
- Patient with Chronic Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI > 15 events/hour)
- Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion)
- Patient available for a program of 3-week SPA Therapy
Who cannot join
- Patient with no social insurance
- Pregnant and nursing woman
- Patient detained by judicial order
- Patient with contra-indication to SPA therapy
- Patient with chronic venous insufficiency < CEAP C3 or CEAP C6
- Patient already treated by class IV compression stockings for severe veinolymphatic insufficiency
Show all 10Show fewer
- Patient already treated for sleep apnea
- Patient who have already benefited of SPA therapy (any type) within 9 months before the enrollment
- Patient with severe comorbidities
- Patient who could not respect the constraints related to the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Medical pratice (angiology)
Annecy
Medical practice (angiology)
Bourgoin
Medical practice (angiology)
Castelnau-le-Lez
University Hospital Grenoble
Grenoble, 38000
Medical pratice (angiology)
Grenoble
University Hospital Grenoble
Grenoble
Clinic Beau Soleil
Montpellier
Medical pratice (angiology)
Tarbes
Medical practice (angiology)
Valence
About this study
Official title: Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study
The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).
Read the detailed description
Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS.
The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome.
The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.
- Being tested
- 3-week immediate SPA treatment, 3-week late SPA treatment
- Keywords
- sleep apnea, Venous Insufficiency, SPA treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week immediate SPA treatmentOther
Also called Immediate SPA treatment
a comprehensive program soon after randomization including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
3-week late SPA treatmentOther
Also called Late SPA treatment
a comprehensive program after 4.5 months, including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
| Study group | Role | What they receive |
|---|---|---|
| Immediate SPA treatment | Active comparator | 3-week immediate SPA treatment (soon after randomization) Receives: Other: 3-week immediate SPA treatment |
| Late SPA treatment | Sham comparator | 3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit) Receives: Other: 3-week late SPA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Variation in AHI according to the allocation group
Measured: 4.5 months
Secondary outcomes (19)
Specific Quality of life
Variation in the scores of CIVIQ 20 according to the allocation group (Specific quality of life scale for venous insufficiency)
Measured: 4.5 months
Global Quality of life
Variation in the score of EUROQUOL according to the allocation group (Global quality of life scale)
Measured: 4.5 months
severity of sleep apnea
Variation of AHI according to the severity of sleep apnea at inclusion. Moderate sleep apnea (AHI <30) vs Severe Sleep apnea (AHI >30) at inclusion
Measured: 4.5 months
Nocturnal hypoxemia
Nocturnal hypoxemia is assessed by mean SpO2 and time spent with SpO2<90%
Measured: 4.5 months
Clinically significant improvement of OSAS
Clinically significant improvement is defined with a reduction in AHI by 50% or more and a reduction in oxygen desaturation index by 50% or more
Measured: 4.5 months
Sleep duration
Mean sleep duration is assessed by actigraphy over a period of 7 days.
Measured: 4.5 months
Quality of Sleep
Quality of sleep is assessed by Quebec Quality of life Questionnaire
Measured: 4.5 months
Daytime sleepiness
Sleepiness is assessed by Epworth sleepiness scale
Measured: 4.5 months
Variation of interstitial fluid
bioimpedance is used to measure interstitial fluid
Measured: 4.5 months
Long term efficacy
Long term efficacy is measured by nocturnal respiratory polygraphy only in patients who are not treated by CPAP
Measured: 1 year
Venous insufficiency classification
Variation of venous insufficiency is assessed by CEAP classification
Measured: 1 year
Venous insufficiency variation
Variation of venous insufficiency is assessed by Villalta score
Measured: 1 year
Venous insufficiency examination
Variation of venous insufficiency is assessed by leg circumferences
Measured: 1 year
long term effect of the SPA treatment on primary outcome
confirmation of the long term effect of the SPA treatment at 1 year for the control group. Primary outcome evolution between 4.5 months and 12 months (evolution of AHI)
Measured: 1 year
long term effect of the SPA treatment on specific quality of life
confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of specific quality of life with CIVIQ 20 scale
Measured: 1 year
long term effect of the SPA treatment on global quality of life
confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of global quality of life with EUROQUOL Scale
Measured: 1 year
long term effect of the SPA treatment on venous insufficiency
confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months of venous insufficiency
Measured: 1 year
long term effect of the SPA treatment on specific treatment of OSAS
confirmation of the long term effect of the SPA treatment at 1 year for the control group. Evolution between 4.5 months and 12 months. The long term effect will be confirmed if patients did not require a specific treatment of OSAS (for example CPAP (Continuous Positive Airway Pressure).
Measured: 1 year
benefit for patients with first SPA treatment
stratification at randomization (first SPA treatment or not) to evaluate a higher benefit (variation of Apnea-Hypopnea Index (AHI)) for patients with first SPA treatment. Comparison of patients with first SPA treatment or not on primary outcome according to the allocation group.
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: no patients randomized after more than one year sponsor decided to withdrawn the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis, University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean Louis PEPIN, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559427
- Sponsor's protocol ID
- THERMA SAS
- Acronym
- THERMA-SAS
- Status last verified
- Jun 2018
- First submitted
- 29 Jul 2015
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
PubMed 18250205Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8. doi: 10.1093/sleep/33.12.1641.
PubMed 21120126Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
PubMed 19743755Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
PubMed 15781100Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.
PubMed 19874994Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
PubMed 10805822Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
PubMed 10080847Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
PubMed 16282178Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. doi: 10.1164/ajrccm.158.2.9712036.
PubMed 9700127Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008.
PubMed 20086074Levy P, Pepin JL, Dematteis M. Pharyngeal neuropathy in obstructive sleep apnea: where are we going? Am J Respir Crit Care Med. 2012 Feb 1;185(3):241-3. doi: 10.1164/rccm.201111-1992ED. No abstract available.
PubMed 22298363Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8. doi: 10.1016/j.ijcard.2004.12.068.
PubMed 16321661Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. J Card Fail. 2009 May;15(4):279-85. doi: 10.1016/j.cardfail.2008.11.015. Epub 2009 Jan 21.
PubMed 19398074de Oliveira Rodrigues CJ, Marson O, Tufic S, Kohlmann O Jr, Guimaraes SM, Togeiro P, Ribeiro AB, Tavares A. Relationship among end-stage renal disease, hypertension, and sleep apnea in nondiabetic dialysis patients. Am J Hypertens. 2005 Feb;18(2 Pt 1):152-7. doi: 10.1016/j.amjhyper.2004.08.028.
PubMed 15752940Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7. doi: 10.1097/00004872-200112000-00022.
PubMed 11725173
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 3-week SPA Therapy on Sleep Apnea in Patients With Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02559427
- Acronym / sponsor ID
- THERMA-SAS / THERMA SAS
- Keywords
- sleep apnea, Venous Insufficiency, SPA treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients randomized after more than one year sponsor decided to withdrawn the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Floralis, University Hospital, Grenoble
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 24 Sep 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.
The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).
Detailed description
Obstructive Sleep Apnea Syndrome (OSAS), characterized by repetitive episodes of partial or complete upper airway (UA) obstruction, is highly prevalent in the general population (2% in women, 4% in men). OSAS is associated with hypersomnolence and it increases the risk of cardiovascular morbidity and mortality. Its pathogenesis is largely multifactorial. In patients with chronic venous insufficiency, fluid retention contributes to this pathogenesis: during the day, fluid accumulates in the legs due to gravity ; during sleep in recumbent position, this accumulated fluid redistributes rostrally in the neck and causes upper airway narrowing and predisposes to OSAS.
The hypothesis is that a comprehensive treatment program for chronic venous insufficiency (SPA therapy) would reduce sleep apnea in patients with chronic venous insufficiency and concomitant sleep apnea Syndrome.
The objective is to assess the efficacy of a 3-week SPA therapy on attenuation of sleep apnea in this population of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate SPA treatment | Active comparator | Other: 3-week immediate SPA treatment3-week immediate SPA treatment (soon after randomization) |
| Late SPA treatment | Sham comparator | Other: 3-week late SPA treatment3-week late SPA treatment (soon after primary endpoint at 4 1/2 months visit) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with Chronic Venous Insufficiency with oedema (CEAP clinical classes C3 to C5) and concomitant Sleep Apnea Syndrome (AHI > 15 events/hour)
- Patient in stable state (no change in medical treatment and no hospitalization for respiratory, cardiac or metabolic event in the 2 months preceding inclusion)
- Patient available for a program of 3-week SPA Therapy
Key exclusion criteria (10 listed)
- Patient with no social insurance
- Pregnant and nursing woman
- Patient detained by judicial order
- Patient with contra-indication to SPA therapy
- Patient with chronic venous insufficiency < CEAP C3 or CEAP C6
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 |
|---|---|---|
| 3-week immediate SPA treatmentAlso: Immediate SPA treatmenta comprehensive program soon after randomization including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...) | Other | Immediate SPA treatment |
| 3-week late SPA treatmentAlso: Late SPA treatmenta comprehensive program after 4.5 months, including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...) | Other | Late SPA treatment |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 4.5 months
Variation in AHI according to the allocation group
19 secondary outcomes
Specific Quality of life
Time frame: 4.5 months
Global Quality of life
Time frame: 4.5 months
severity of sleep apnea
Time frame: 4.5 months
Nocturnal hypoxemia
Time frame: 4.5 months
Clinically significant improvement of OSAS
Time frame: 4.5 months
Sleep duration
Time frame: 4.5 months
Quality of Sleep
Time frame: 4.5 months
Daytime sleepiness
Time frame: 4.5 months
Variation of interstitial fluid
Time frame: 4.5 months
Long term efficacy
Time frame: 1 year
Venous insufficiency classification
Time frame: 1 year
Venous insufficiency variation
Time frame: 1 year
Venous insufficiency examination
Time frame: 1 year
long term effect of the SPA treatment on primary outcome
Time frame: 1 year
long term effect of the SPA treatment on specific quality of life
Time frame: 1 year
long term effect of the SPA treatment on global quality of life
Time frame: 1 year
long term effect of the SPA treatment on venous insufficiency
Time frame: 1 year
long term effect of the SPA treatment on specific treatment of OSAS
Time frame: 1 year
benefit for patients with first SPA treatment
Time frame: 4.5 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 29 Jun 2018.
- Background: PubMed 18250205Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
- Background: PubMed 21120126Caffo B, Diener-West M, Punjabi NM, Samet J. A novel approach to prediction of mild obstructive sleep disordered breathing in a population-based sample: the Sleep Heart Health Study. Sleep. 2010 Dec;33(12):1641-8. doi: 10.1093/sleep/33.12.1641.
- Background: PubMed 19743755Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Background: PubMed 15781100Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Background: PubMed 19874994Monahan K, Storfer-Isser A, Mehra R, Shahar E, Mittleman M, Rottman J, Punjabi N, Sanders M, Quan SF, Resnick H, Redline S. Triggering of nocturnal arrhythmias by sleep-disordered breathing events. J Am Coll Cardiol. 2009 Nov 3;54(19):1797-804. doi: 10.1016/j.jacc.2009.06.038.
- Background: PubMed 10805822Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
- Background: PubMed 10080847Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.
- Background: PubMed 16282178Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
- Background: PubMed 9700127Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. doi: 10.1164/ajrccm.158.2.9712036.
- Background: PubMed 20086074Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008.
- Background: PubMed 22298363Levy P, Pepin JL, Dematteis M. Pharyngeal neuropathy in obstructive sleep apnea: where are we going? Am J Respir Crit Care Med. 2012 Feb 1;185(3):241-3. doi: 10.1164/rccm.201111-1992ED. No abstract available.
- Background: PubMed 16321661Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8. doi: 10.1016/j.ijcard.2004.12.068.
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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 principal investigator
University Hospital, Grenoble
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-week immediate SPA treatment and 3-week late SPA treatment in people with Obstructive Sleep Apnea Syndrome and Chronic Venous Insufficiency, run by Association Francaise pour la Recherche Thermale at 9 sites 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 3 inclusion and 10 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
Apnea-Hypopnea Index (AHI) (time frame: 4.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559427, which also lists 34 linked publications.
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 29 Jun 2018.