Obstructive Sleep Apnea Hypopnea SyndromeESSINCT03845062
Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
An observational study of Obstructive Sleep Apnea Hypopnea Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea Syndrome
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 1 Aug 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center
Who may be able to join
- OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography)
Who cannot join
- Lack of data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.
Read the detailed description
Retrospective single center study of 31 children (mean age: 5.5 ± 2.6 years) who benefited from DISE between 2015 and 2018 in the management of OSAHS. Modification of therapeutic management was noted. A correlation between the number of obstructive sites and the IAH on the one hand, and between the number of obstructive sites and the type of SAHOS on the other hand, was sought.
- Keywords
- drug-induced sleep endoscopy, pediatric obstructive sleep apnea hypopnea syndrome, tongue base, epiglottis, occult laryngomalacia, lingual tonsillectomy, epiglottopexy, aryepiglottic folds division
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep endoscopy
describe the modification of therapeutic management induced by sleep endoscopy
Measured: 1 day
Secondary outcomes (3)
Number of obstructive site during
retrospective data collection : Number of obstructive site during
Measured: 1 day
value of apnea-hypopnea index
retrospective data collection : value of apnea-hypopnea index
Measured: 1 day
type obstructive hypopnoea apnea syndrome of sleep
type obstructive hypopnoea apnea syndrome of sleep. Children facing craniofacial or neuromuscular disorders were rated in "Type III OSAHS". Obese children were rated in "Type II OSAHS". Others children were rated by default in "Type I OSAHS".
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Oct 2015
- Primary completion1 Jun 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea Hypopnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Akkari, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845062
- Sponsor's protocol ID
- RECHMPL18_0333
- Acronym
- ESSI
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT03845062
- Acronym / sponsor ID
- ESSI / RECHMPL18_0333
- Keywords
- drug-induced sleep endoscopy, pediatric obstructive sleep apnea hypopnea syndrome, tongue base, epiglottis, occult laryngomalacia, lingual tonsillectomy, epiglottopexy, aryepiglottic folds division
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 19 Feb 2019 (actual)
- 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 role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.
Detailed description
Retrospective single center study of 31 children (mean age: 5.5 ± 2.6 years) who benefited from DISE between 2015 and 2018 in the management of OSAHS. Modification of therapeutic management was noted. A correlation between the number of obstructive sites and the IAH on the one hand, and between the number of obstructive sites and the type of SAHOS on the other hand, was sought.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center
Key inclusion criteria (1 listed)
- OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography)
Key exclusion criteria (1 listed)
- Lack of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep endoscopy
Time frame: 1 day
describe the modification of therapeutic management induced by sleep endoscopy
3 secondary outcomes
Number of obstructive site during
Time frame: 1 day
value of apnea-hypopnea index
Time frame: 1 day
type obstructive hypopnoea apnea syndrome of sleep
Time frame: 1 day
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 19 Feb 2019.
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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.
Mohamed Akkari, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Hypopnea Syndrome, run by University Hospital, Montpellier 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 1 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 19 Feb 2019. 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?
sleep endoscopy (time frame: 1 day). 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 19 Feb 2019.