Obstructive Sleep ApneaNCT06367400
Validation of Pediatric Sleep Questionnaire on a Swedish Cohort
An observational study of Obstructive Sleep Apnea and Sleep Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 months to 15 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Disorder, Sleep Disorders in Children
- What is being tested?
- Pediatric Sleep Questionnaire
- How many people
- 520 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2024to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 months to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will be included from the ENT-clinics or the waiting lists to surgical treatments.
Who may be able to join
- Children with OSDB-symptoms referred to ENT-clinics
- Age between 18 months and 15 years old.
- Good knowledge of the Swedish language
Who cannot join
- Craniofacial abnormalities
- Mb Down
- neuromuscular disorders
- do not understand swedish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Akademiska hospital
Uppsala
Isabella Sjölander, 018-6110000, isabella.sjolander@uu.se
About this study
Official title: Validation of Pediatric Sleep Questionnaire, a Multi-center Study in Sweden
This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.
- Conditions
- Obstructive Sleep Apnea, Sleep Disorder, Sleep Disorders in Children, Obstructive Sleep Apnea of Child
- Being tested
- Pediatric Sleep Questionnaire
- Keywords
- OSDB, PSQ, Pediatrics
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Sleep QuestionnaireDiagnostic test
Questionnaire with 22 questions of symptoms of OSDB
| Study group | Role | What they receive |
|---|---|---|
| PSQ-cohort | Patients recruited from Akademiska Sjukhuset, Örebro, Västra Götaland, Skåne, Stockholm and Umeå. Receives: Diagnostic Test: Pediatric Sleep Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of baseline PSQ
Level of baseline PSQ of children who are referred to surgery. A level of >33% yes i.e. 8/22 indicates medium to severe OSA and less than five yes indicates a healthy status. Minimum is 0 yes and maximum is 22 where 22 is the most severe disease.
PSQ has a score from 0 to 22 where every yes on the scale is one point. A level of 8 "yes" (>33%) indicates moderate to severe OSDB and less than five indicates no OSDB.
Measured: Baseline
Changes of baseline PSQ after treatment
Changes of baseline PSQ with 6 months follow-up, after treatment/surgery
Measured: 6 months to 12 months
Secondary outcomes (3)
PSQ vs OSA-18
Compare PSQ-levels with OSA-18 levels OSA-18 is accounted as a scale from 18 to 126 points where a higher rate is a more severe disease. Score less than 60 suggests a mild impact on quality of life. Scores between 60 and 80 a moderate impact and a score higher than 80 severe impact.
OSA-18 has a summary of 18 - 126 points where a higher level indicates worse quality of life. A score less than 60 indicates a mild impact on quality of life and score between 60 and 80 indicates moderate impact whereas a score above 80 indicates a high impact.
Measured: 6 months
PSQ vs. PSG
PSQ-levels compared to Polysomnography outcomes
Measured: 6 months
PSQ levels of healthy controls vs children with OSDB
Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2034 (estimated)
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.
- More trials run by Uppsala UniversityThe 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
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Örebro University, Sweden, Umeå University, Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367400
- Sponsor's protocol ID
- SwePSQ
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pediatric Sleep Questionnaire, a Multi-center Study in Sweden
- ClinicalTrials.gov ID
- NCT06367400
- Acronym / sponsor ID
- SwePSQ
- Conditions
- Obstructive Sleep Apnea, Sleep Disorder, Sleep Disorders in Children, Obstructive Sleep Apnea of Child
- Keywords
- OSDB, PSQ, Pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Örebro University, Sweden, Umeå University, Göteborg University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 16 Apr 2024 (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.
This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSQ-cohort | – | Diagnostic Test: Pediatric Sleep QuestionnairePatients recruited from Akademiska Sjukhuset, Örebro, Västra Götaland, Skåne, Stockholm and Umeå. |
Who may qualify
- Ages
- 18 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will be included from the ENT-clinics or the waiting lists to surgical treatments.
Key inclusion criteria (3 listed)
- Children with OSDB-symptoms referred to ENT-clinics
- Age between 18 months and 15 years old.
- Good knowledge of the Swedish language
Key exclusion criteria (4 listed)
- Craniofacial abnormalities
- Mb Down
- neuromuscular disorders
- do not understand swedish
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 |
|---|---|---|
| Pediatric Sleep QuestionnaireQuestionnaire with 22 questions of symptoms of OSDB | Diagnostic test | PSQ-cohort |
Primary outcome
Level of baseline PSQ
Time frame: Baseline
Level of baseline PSQ of children who are referred to surgery. A level of >33% yes i.e. 8/22 indicates medium to severe OSA and less than five yes indicates a healthy status. Minimum is 0 yes and maximum is 22 where 22 is the most severe disease. PSQ has a score from 0 to 22 where every yes on the scale is one point. A level of 8 "yes" (>33%) indicates moderate to severe OSDB and less than five indicates no OSDB.
Changes of baseline PSQ after treatment
Time frame: 6 months to 12 months
Changes of baseline PSQ with 6 months follow-up, after treatment/surgery
3 secondary outcomes
PSQ vs OSA-18
Time frame: 6 months
PSQ vs. PSG
Time frame: 6 months
PSQ levels of healthy controls vs children with OSDB
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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.
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 and Sleep Disorder, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Apr 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Sjölander (018-6110000, isabella.sjolander@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of baseline PSQ (time frame: Baseline). The study lists 2 primary outcomes in all. 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 16 Apr 2024.