Sleep Disorder; Breathing-RelatedNCT03478566
Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
A study testing Transcutaneous CO2 monitoring in people with Sleep Disorder; Breathing-Related and Central Apnea, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases
- What is being tested?
- Transcutaneous CO2 monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Sep 2023
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
- lives within the greater Toronto area.
Who cannot join
- known diagnosis of nocturnal hypoventilation
- current ventilatory support
- physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.
- Conditions
- Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases, Obstructive Sleep Apnea
- Being tested
- Transcutaneous CO2 monitoring
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea, Central, Neuromuscular Diseases, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous CO2 monitoringDevice
The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous CO2 monitoring | Experimental | Not described Receives: Device: Transcutaneous CO2 monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
Measured: 9 months
Secondary outcomes (1)
a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation.
- Correlation of the pre and post sleep capillary blood gas results with end tidal CO2 (etCO2) and tcCO2 recordings during PSG.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2021
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorder; Breathing-RelatedStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reshma Amin, The Hospital for Sick Children
- Investigators
- Reshma Amin, MD, Principal investigator, Staff Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478566
- Sponsor's protocol ID
- 1000059242
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2018
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Shi J, Chiang J, Ambreen M, Snow N, Mocanu C, McAdam L, Goldstein RS, Rose L, Amin R. Ambulatory transcutaneous carbon dioxide monitoring for children with neuromuscular disease. Sleep Med. 2023 Jan;101:221-227. doi: 10.1016/j.sleep.2022.10.028. Epub 2022 Nov 2.
PubMed 36435158
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT03478566
- Acronym / sponsor ID
- 1000059242
- Conditions
- Sleep Disorder; Breathing-Related, Central Apnea, Neuromuscular Diseases, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Mar 2018 (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.
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous CO2 monitoring | Experimental | Device: Transcutaneous CO2 monitoring |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
- lives within the greater Toronto area.
Key exclusion criteria (3 listed)
- known diagnosis of nocturnal hypoventilation
- current ventilatory support
- physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
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 |
|---|---|---|
| Transcutaneous CO2 monitoringThe aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD). | Device | Transcutaneous CO2 monitoring |
Primary outcome
Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
Time frame: 9 months
1 secondary outcome
a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation.
Time frame: 9 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 11 Apr 2023.
- Derived from this study: PubMed 36435158Shi J, Chiang J, Ambreen M, Snow N, Mocanu C, McAdam L, Goldstein RS, Rose L, Amin R. Ambulatory transcutaneous carbon dioxide monitoring for children with neuromuscular disease. Sleep Med. 2023 Jan;101:221-227. doi: 10.1016/j.sleep.2022.10.028. Epub 2022 Nov 2.
- Individual participant dataSharing planned: Undecided
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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.
Reshma Amin, MD principal investigator
Staff Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous CO2 monitoring in people with Sleep Disorder; Breathing-Related and Central Apnea, run by The Hospital for Sick Children at 1 site in Canada.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Apr 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 Canada. 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?
Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG). (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478566, which also lists 1 linked publication.
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 11 Apr 2023.