Sleep Apnea Syndromes in ChildrenNCT06172868
Home Ventilatory Support in Children
An observational study of Sleep Apnea Syndromes in Children, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Sleep Apnea Syndromes in Children
- How many people
- 94 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2020to 1 Dec 2027
- 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 Up to 16 years
- All sexes
- Child
Study population: 93 patients treated by a multidisciplinary paediatric home ventilatory support -team from January 2010 to December 2020 in Tampere University Hospital. The individuals were identified combining two sources: the team´s clinical list of patients and a database search from patient records with ICD-10 diagnose G47.3 (Sleep Apnea) in Pediatric Patient records.
Who may be able to join
- ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list
Who cannot join
- Age over 16
- Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010
- patients with sleep apnea but without home respiratory support treatment
- Only theophylline treatment
- High-flow oxygen therapy
- Age over 16 at treatment onset
- Never started treatment
- Treatment starting point and ending before year 2010
Trial locations and contacts
1 site in 1 country.
About this study
The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL).
- Conditions
- Sleep Apnea Syndromes in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland
Data included patient demographics
Measured: 2022-2023
Number of patients with clinical characteristics
Data included underlying medical conditions and medications. The circumstances for home respiratory support onset, frequency of follow-up, complications, operative interventions to treat sleep apnea before and during period with home respiratory support were collected. The type of respiratory support (device, mode, interface) was recorded.
Measured: 2022-2023
Secondary outcomes (1)
The duration of treatment
The duration of treatment during January 2010 to December 2020 in Tampere University Hospital, Finland were collected.
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndromes in ChildrenStudies of the same condition, open and under way.
- More trials run by Tampere 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172868
- Sponsor's protocol ID
- R210861
- Status last verified
- Dec 2023
- First submitted
- 8 Aug 2022
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Ventilatory Support in Children
- ClinicalTrials.gov ID
- NCT06172868
- Acronym / sponsor ID
- R210861
- Conditions
- Sleep Apnea Syndromes in Children
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Dec 2023 (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 study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- 93 patients treated by a multidisciplinary paediatric home ventilatory support -team from January 2010 to December 2020 in Tampere University Hospital. The individuals were identified combining two sources: the team´s clinical list of patients and a database search from patient records with ICD-10 diagnose G47.3 (Sleep Apnea) in Pediatric Patient records.
Key inclusion criteria (1 listed)
- ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list
Key exclusion criteria (8 listed)
- Age over 16
- Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010
- patients with sleep apnea but without home respiratory support treatment
- Only theophylline treatment
- High-flow oxygen therapy
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
Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland
Time frame: 2022-2023
Data included patient demographics
Number of patients with clinical characteristics
Time frame: 2022-2023
Data included underlying medical conditions and medications. The circumstances for home respiratory support onset, frequency of follow-up, complications, operative interventions to treat sleep apnea before and during period with home respiratory support were collected. The type of respiratory support (device, mode, interface) was recorded.
1 secondary outcome
The duration of treatment
Time frame: 2022-2023
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 15 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syndromes in Children, run by Tampere University Hospital at 1 site in Finland.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2023. 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 Finland. 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?
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?
Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland (time frame: 2022-2023). 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 15 Dec 2023.