Sleep Apnea, ObstructiveNCT02463201
Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
An observational study of Sleep Apnea, Obstructive and Pediatric Obesity, run by Zealand University Hospital at 2 sites in Denmark.
Trial summary
The prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Pediatric Obesity
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 236 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2015to Jun 2018
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The cohort consists of children attending the Childrens Obesity Clinic in Holbaek.
Who may be able to join
- Age: 7-18 years
- BMI > 90th percentile for age and gender
Who cannot join
- Neuromuscular disorders
- Craniofacial syndromes / malformations
- Laryngeal and tracheal malformations
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Holbaek Sygehus
Holbæk, Danmark, 4300
Zealand University Hospital
Køge, Danmark, 4600
About this study
The prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. The correlation between obesity and OSA is still poorly understood. Early detection and intervention is of great importance as the health consequences related to OSA as well as obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with OSA. However, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to OSA in obese children.
In this study the investigators aim to clarify the impact of obesity in the development of OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is to assess the effect of weight loss on OSA.
- Conditions
- Sleep Apnea, Obstructive, Pediatric Obesity
- Being tested
- Weight loss
- Keywords
- Sleep Apnea, Obstructive, Pediatric Obesity
- Medical subject headings
- Sleep Apnea, Obstructive, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Obese children and adolescents | Attending a weightloss programme, that consist of lifestyle counseling, dietary restriction and exercise. The prevalence of obstructive sleep apnea (OSA) will be investigated in group. Children diagnosed with OSA will be followed to investigate if weight loss changes the condition. Receives: Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in obstructive sleep apnea (OSA)
OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus
- Responsible party
- Sponsor
- Investigators
- Ida Andersen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463201
- Sponsor's protocol ID
- SJ-404
- Status last verified
- Dec 2018
- First submitted
- 2 Jun 2015
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Orntoft M, Andersen IG, Homoe P. Agreement between manual and automatic analyses of home sleep examinations in pediatric obstructive sleep apnea. J Comp Eff Res. 2019 Jun;8(8):623-631. doi: 10.2217/cer-2018-0093. Epub 2019 May 24.
PubMed 31122047
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
- ClinicalTrials.gov ID
- NCT02463201
- Acronym / sponsor ID
- SJ-404
- Conditions
- Sleep Apnea, Obstructive, Pediatric Obesity
- Keywords
- Sleep Apnea, Obstructive, Pediatric Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Holbaek Sygehus
- Study start
- Apr 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Jun 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 prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. The correlation between obesity and OSA is still poorly understood. Early detection and intervention is of great importance as the health consequences related to OSA as well as obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with OSA. However, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to OSA in obese children.
In this study the investigators aim to clarify the impact of obesity in the development of OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is to assess the effect of weight loss on OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese children and adolescents | – | Behavioral: Weight lossAttending a weightloss programme, that consist of lifestyle counseling, dietary restriction and exercise. The prevalence of obstructive sleep apnea (OSA) will be investigated in group. Children diagnosed with OSA will be followed to investigate if weight loss changes the condition. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The cohort consists of children attending the Childrens Obesity Clinic in Holbaek.
Key inclusion criteria (2 listed)
- Age: 7-18 years
- BMI > 90th percentile for age and gender
Key exclusion criteria (3 listed)
- Neuromuscular disorders
- Craniofacial syndromes / malformations
- Laryngeal and tracheal malformations
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 |
|---|---|---|
| Weight loss | Behavioural | Obese children and adolescents |
Primary outcome
Change in obstructive sleep apnea (OSA)
Time frame: One year
OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.
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 13 Dec 2018.
- Derived from this study: PubMed 31122047Orntoft M, Andersen IG, Homoe P. Agreement between manual and automatic analyses of home sleep examinations in pediatric obstructive sleep apnea. J Comp Eff Res. 2019 Jun;8(8):623-631. doi: 10.2217/cer-2018-0093. Epub 2019 May 24.
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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.
Ida Andersen, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Pediatric Obesity, run by Zealand University Hospital at 2 sites in Denmark.
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 3 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 in obstructive sleep apnea (OSA) (time frame: One year). 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 NCT02463201, which also lists 1 linked publication.
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 13 Dec 2018.