Obstructive Sleep ApneaNCT02732431
Obstructive Sleep Apnea and Down Syndrome: Clinical Examination Issue
A study testing Sleep Symptom in people with Obstructive Sleep Apnea, run by Fondation Lenval at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep Symptom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2013to 31 Dec 2014
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age under 18 years
- Down syndrome with cytogenetic diagnosis
- State health cover
- Consent of legal representative and/or patient
Who cannot join
- Polysomnography with correct results during the 12 months before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.
Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.
Read the detailed description
Introduction: Children with Down syndrome (DS) commonly have obstructive sleep apnea (OSA) though undervalued by parents and physicians. Several sleep questionnaires are used in paediatric patients to detect high risk children who have OSA, but not really appropriate for DS patients. The aim of the study is to determine the reliability of four questionnaires used in paediatric patients (PSQ-SRBD: Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder, CSHQ: Children's Sleep Habits Questionnaire, CAS-15: Clinical Assessment Score-15 and SCR: Sleep Clinical Record) in screening of OSA in DS population.
Study design: Prospective study concerning children with Down syndrome (age 1-18y). Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep Symptom
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep SymptomOther
Questionnaires, skin allergy test, overnight polysomnography
| Study group | Role | What they receive |
|---|---|---|
| trisomy 21 | Other | Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice. Receives: Other: Sleep Symptom |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population
Sensitivity each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
Secondary outcomes (6)
determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population
specificity of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
positive predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
negative predictive value of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
positive likelihood of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
negative likelihood ratio of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
determine the reliability of area under a receiver operating characteristic (ROC) curve of four questionnaires used in paediatric patients in screening of OSA in DS population
area under a receiver operating characteristic (ROC) curve of each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start10 Oct 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lisa CHAMI, MD, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732431
- Sponsor's protocol ID
- 14-HPNCL-06
- Status last verified
- Jul 2018
- First submitted
- 22 Mar 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Screening and Down Syndrome in Childhood : the Reliability of the Clinical Examination
- ClinicalTrials.gov ID
- NCT02732431
- Acronym / sponsor ID
- 14-HPNCL-06
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 8 Apr 2016 (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.
Obstructive sleep apnea (OSA) is a common condition of Down syndrome patients. In pediatric practice, there is no way to determine the children with an increased risk. The aim of the study is to determine the reliability of four questionnaires used in pediatric patients in screening of OSA in Down syndrome children.
Prospective study where patients are evaluated on airway diseases and aeroallergens sensitization with 2 parental surveys (PSQ-SRBD and CSHQ), otolaryngologic problems by completing by the ENT surgeon 2 others surveys (CAS-15 and SCR), and sleep disease with an overnight polysomnography (PSG), in University Hospital in Nice.
Detailed description
Introduction: Children with Down syndrome (DS) commonly have obstructive sleep apnea (OSA) though undervalued by parents and physicians. Several sleep questionnaires are used in paediatric patients to detect high risk children who have OSA, but not really appropriate for DS patients. The aim of the study is to determine the reliability of four questionnaires used in paediatric patients (PSQ-SRBD: Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder, CSHQ: Children's Sleep Habits Questionnaire, CAS-15: Clinical Assessment Score-15 and SCR: Sleep Clinical Record) in screening of OSA in DS population.
Study design: Prospective study concerning children with Down syndrome (age 1-18y). Parents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trisomy 21 | Other | Other: Sleep SymptomParents will complete two sleep symptom questionnaires (PSQ-SRBD and CSHQ) and children will be evaluated by a paediatric pulmonologist and allergist with skin allergy test. An Ear, Nose and Throat specialist will complete two questionnaires (CAS-15 and SCR) carrying a nasopharyngoscopy. Then, children will perform an overnight polysomnography in the Department of Paediatric Functional Investigations of University Hospital in Nice. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age under 18 years
- Down syndrome with cytogenetic diagnosis
- State health cover
- Consent of legal representative and/or patient
Key exclusion criteria (1 listed)
- Polysomnography with correct results during the 12 months before
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 |
|---|---|---|
| Sleep SymptomQuestionnaires, skin allergy test, overnight polysomnography | Other | trisomy 21 |
Primary outcome
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
Sensitivity each survey (PSQ-SRBD, CSHQ, CAS-15, SCR) depending on the obstructive apnea-hypopnea index in the group if children who have an OSA syndrome.
6 secondary outcomes
determine the reliability of the specificity of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
determine the reliability of positive predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
determine the reliability of negative predictive value of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
determine the reliability of positive likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
determine the reliability of negative likelihood ratio of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
determine the reliability of area under a receiver operating characteristic (ROC) curve of four questionnaires used in paediatric patients in screening of OSA in DS population
Time frame: At the inclusion
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 30 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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.
lisa CHAMI, MD principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Symptom in people with Obstructive Sleep Apnea, run by Fondation Lenval 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 4 inclusion and 1 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 30 Jul 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?
determine the reliability of the Sensitivity of four questionnaires used in paediatric patients in screening of OSA in DS population (time frame: At the inclusion). 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 30 Jul 2018.