Sleep ApneaCHILDSLEEPNCT04340310
Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP).
An observational study of Sleep Apnea and Home Respiratory Polygraphy Sleep Study, run by Hospital Universitario San Juan de Alicante at 1 site in Spain.
Trial summary
The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Sleep Apnea, Home Respiratory Polygraphy Sleep Study, Childhood Sleep Apnea
- What is being tested?
- Home respiratory polygraphy
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2019to 6 Apr 2022
- How long will I take part?
- 2 Years
- 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 4 to 14 years
- All sexes
- Child
Study population: Children submited to Pneumology Service with sleep apnea suspicion
Who may be able to join
- Sleep apnea suspicion
Who cannot join
- Other sleep conditions
- Non valid home respiratory polygraphy and non valid polysomnography in the same patient
- Non informated consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Eusebio Chiner Vives
Sant Joan d'Alacant, Alicante, 03550
Eusebi Chiner-Vives, MD, PhD, +34699445131, echinervives@gmail.com
Cistina Cánovas-Galindo, MD
About this study
Official title: Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome
The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.
Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.
- Conditions
- Sleep Apnea, Home Respiratory Polygraphy Sleep Study, Childhood Sleep Apnea, Polysomnography, Therapeutic Decision
- Being tested
- Home respiratory polygraphy
- Keywords
- Childhood sleep apnea, Sleep apnea syndrome, Obstructive apnea syndrome, Obstructive apnea sleep
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home respiratory polygraphyDiagnostic test
Also called Polysomnography
Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission
| Study group | Role | What they receive |
|---|---|---|
| Home respiratory poligraphy | Group A: Children between 4 and 14 years-old with initial OSA suspicion there will be allocated to Home Respiratory Polygraphy (HRP) Receives: Diagnostic Test: Home respiratory polygraphy | |
| Polysomnography | Group B: Children between 4 and 14 years-old with initial OSA suspicion and concommitant diseases and false negative suspicion from HRP there will allocated to Hospital Nocturnal Polysomnography Receives: Diagnostic Test: Home respiratory polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.
False negative and true positive diagnosis by home respiratory polygraphy
Measured: two years
Secondary outcomes (1)
To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations
Number of chlidhood sleep consultations related to adult consultations
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start6 Feb 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion6 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Juan de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eusebi Chiner, Hospital Universitario San Juan de Alicante
- Investigators
- Eusebi Chiner Vives, Principal investigator, Hospital Universitario San Juan de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340310
- Sponsor's protocol ID
- CEIC (HUSJ-20-003)
- Acronym
- CHILDSLEEP
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific publication, Sleep spanish network
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT04340310
- Acronym / sponsor ID
- CHILDSLEEP / CEIC (HUSJ-20-003)
- Conditions
- Sleep Apnea, Home Respiratory Polygraphy Sleep Study, Childhood Sleep Apnea, Polysomnography, Therapeutic Decision
- Keywords
- Childhood sleep apnea, Sleep apnea syndrome, Obstructive apnea syndrome, Obstructive apnea sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hospital Universitario San Juan de AlicanteUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 6 Apr 2022 (estimated)
- First posted
- 9 Apr 2020 (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 aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.
Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home respiratory poligraphy | – | Diagnostic Test: Home respiratory polygraphyGroup A: Children between 4 and 14 years-old with initial OSA suspicion there will be allocated to Home Respiratory Polygraphy (HRP) |
| Polysomnography | – | Diagnostic Test: Home respiratory polygraphyGroup B: Children between 4 and 14 years-old with initial OSA suspicion and concommitant diseases and false negative suspicion from HRP there will allocated to Hospital Nocturnal Polysomnography |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Children submited to Pneumology Service with sleep apnea suspicion
Key inclusion criteria (1 listed)
- Sleep apnea suspicion
Key exclusion criteria (3 listed)
- Other sleep conditions
- Non valid home respiratory polygraphy and non valid polysomnography in the same patient
- Non informated consent
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 |
|---|---|---|
| Home respiratory polygraphyAlso: PolysomnographyHome respiratory polygraphy or Polysomnography to stablish a therapeutic decission | Diagnostic test | Home respiratory poligraphy, Polysomnography |
Primary outcome
To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.
Time frame: two years
False negative and true positive diagnosis by home respiratory polygraphy
1 secondary outcome
To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: Yes. Scientific publication, Sleep spanish network
Related trials for Sleep Apnea
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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.
Eusebi Chiner Vives principal investigator
Hospital Universitario San Juan de Alicante
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 Sleep Apnea and Home Respiratory Polygraphy Sleep Study, run by Hospital Universitario San Juan de Alicante at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 10 Apr 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eusebi Chiner Vives, MD, PhD (609017275, echinervives@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions. (time frame: two years). 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 10 Apr 2020.