Pediatric ObesityOBESOMACNCT02588469
Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA
A study testing Interventional group in people with Pediatric Obesity and Sleep Apnea, Obstructive, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Pediatric Obesity, Sleep Apnea, Obstructive
- What is being tested?
- Interventional group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2015to Jun 2016
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obese adolescents (BMI > 97th percentile),
- patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),
- enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- without observed tonsils hypertrophy (Mallampati and Friedman scores),
- without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- with physical activity certificate issued by a cardiologist
- covered by the national insurance scheme of his/her legal representative,
- having signed, as well as his(her) legal representative, the informed consent of participation.
Who cannot join
- Non obese adolescents (BMI < 97th percentile)
- patients aged under 12 or over 17 years old,
- not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- with observed tonsils hypertrophy (Mallampati and Friedman scores),
- with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
- without physical activity certificate issued by a cardiologist
- uncovered by the national insurance scheme of his/her legal representative,
- not having signed, as well as his(her) legal representative, the informed consent of participation.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de soins de suite et de réadaptation La Beline
Salins-les-Bains, 39110
About this study
Official title: Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.
Read the detailed description
Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.
Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.
It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.
- Conditions
- Pediatric Obesity, Sleep Apnea, Obstructive
- Being tested
- Interventional group, Control group
- Keywords
- pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift
- Medical subject headings
- Pediatric Obesity, Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional groupOther
Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.
Control groupOther
Standard obesity care with physical activity program
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Physical activity program coupled with compression socks wearing during 3 months. Receives: Other: Interventional group |
| control group | Active comparator | Physical activity program without compression socks during 3 months. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Obstructive sleep apnea severity at 3 months.
Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary outcomes (10)
Upper airway resistances
upper airway resistance will be assessed by acoustic method
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Fluid shift
fluid shift will be assessed by bioimpedance analysis
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Calf and neck circumferences
Calf and neck circumferences will be assessed with nonelastic tape
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Calf and neck circumferences
Calf and neck circumferences will be assessed by plethysmography
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Anthropometric parameters
weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Body composition
fat mass, fat free mass ( by bioimpedance analysis)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Pulmonary function during exercise
Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Metabolic responses
Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Hormonal responses
Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Inflammatory responses
C-reactive protein (ELISA and RIA technics)
Measured: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start27 Aug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588469
- Sponsor's protocol ID
- P/2015/250
- Acronym
- OBESOMAC
- Status last verified
- Jan 2018
- First submitted
- 22 Jul 2015
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
PubMed 32008915Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.
PubMed 29852904
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02588469
- Acronym / sponsor ID
- OBESOMAC / P/2015/250
- Conditions
- Pediatric Obesity, Sleep Apnea, Obstructive
- Keywords
- pediatric obesity, obstructive sleep apnea, physical exercise, compression socks, rostral fluid shift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 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.
The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.
Detailed description
Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.
Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.
It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.
To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Interventional groupPhysical activity program coupled with compression socks wearing during 3 months. |
| control group | Active comparator | Other: Control groupPhysical activity program without compression socks during 3 months. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Obese adolescents (BMI > 97th percentile),
- patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197),
- enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- without observed tonsils hypertrophy (Mallampati and Friedman scores),
- without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
Key exclusion criteria (8 listed)
- Non obese adolescents (BMI < 97th percentile)
- patients aged under 12 or over 17 years old,
- not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management,
- with observed tonsils hypertrophy (Mallampati and Friedman scores),
- with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography,
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 |
|---|---|---|
| Interventional groupVenous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management. To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA. | Other | Interventional group |
| Control groupStandard obesity care with physical activity program | Other | control group |
Primary outcome
Change from Obstructive sleep apnea severity at 3 months.
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months
10 secondary outcomes
Upper airway resistances
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Fluid shift
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Calf and neck circumferences
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Calf and neck circumferences
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Anthropometric parameters
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Body composition
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Pulmonary function during exercise
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Metabolic responses
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Hormonal responses
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Inflammatory responses
Time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Derived from this study: PubMed 32008915Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
- Derived from this study: PubMed 29852904Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional group in people with Pediatric Obesity and Sleep Apnea, Obstructive, run by Centre Hospitalier Universitaire de Besancon 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 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: finished, as of the sponsor's last update on 24 Jan 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Obstructive sleep apnea severity at 3 months. (time frame: This study includes 2 assessments : baseline (T0) and 3 months (T3)). 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 NCT02588469, which also lists 2 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 24 Jan 2018.