An interventional study of 15% oxygen in Neuromuscular Diseases and High Altitude Hypoxia, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic
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Among 34 studies in Neuromuscular Diseases with a site in Canada — 9 open to participants now, 12 under way, 1 of them phase 3. Neuromuscular Diseases · Canada.
Among the 34 studies in Neuromuscular Diseases with a site in Canada, this one is the 26th largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2016, is one of 7 with no phase, and was the 11th registered.
361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.
Browse Neuromuscular Diseases studies →9 of the 34 studies in Neuromuscular Diseases with a site in Canada are open now. Recruiting first, the newest first:
Avidity Biosciences, Inc. · Sites in Canada, Australia, Belgium and 7 more countries
Ages 7–16 · Men only
PepGen Inc · Sites in Canada
AstraZeneca · Sites in Canada, United States, China and 7 more countries
Ages 18–70
Children's Hospital of Eastern Ontario · Sites in Canada
Ages up to 18
Université de Sherbrooke · Sites in Canada
Ages 18+ · Women only
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 70 Neuromuscular Diseases studies recruiting now, 39 (56%) set no upper age limit and 23 (33%) stop at 75 or younger; 36 take children under 18; 16 take healthy volunteers.
This study: 5 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 11
First in 2012; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 23 is below the median of 30 across 204 interventional studies indexed under Neuromuscular Diseases.
Median enrollment 75 across the 28 interventional studies, 370 across the 6 observational. Of the 22 that completed or were terminated, 11 (50%) have results posted.
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21 of 34 have an industry lead sponsor. The 10 most frequent:
The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
The Hospital for Sick Children has 3 studies filed under Neuromuscular Diseases — fewer than ten, so there is no comparison to draw.
5 of the studies in Neuromuscular Diseases with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06316778Université de SherbrookePelvic Floor Muscle Training for Women with Myotonic Dystrophy | 2026-12-30 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT07287189Satellos Bioscience, Inc.Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients | 2027-03-31 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT06438965Children's Hospital of Eastern OntarioMSOT As Non-invasive Biomarker for Diagnosis and Monitoring of Neuromuscular Diseases | 2027-07 |
Add all 5 to your calendar (.ics) → With an account.
Among the 34 studies in Neuromuscular Diseases with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To determine if a prolonged high altitude simulation test (HAST) lasting two hours, identifies more patients at risk of respiratory failure than the standard HAST lasting 20 minutes, in patients with neuromuscular disease (NMD) and severe pulmonary restriction. To evaluate the safety of supplemental oxygen administered in those with a positive HAST in the NMD population.
Study Procedures
Patients were screened for eligibility during a regularly scheduled clinic visit in which spirometry was performed in accordance with the American Thoracic Society recommendations.4 If eligible, they were approached by a Research Coordinator and invited to participate in the study. The study visit was organized within 4 weeks of screening and included both diagnostic and (if applicable) therapeutic HCT trials. After enrolment, patients' local medical records were reviewed for baseline data.
Baseline Assessment:
On the day of the HCT, a brief focused history including current respiratory symptoms was performed. Study participants sat for a minimum of 5 minutes before baseline measurements were taken. Vital signs (heart rate, respiratory rate, blood pressure), capillary blood gas, transcutaneous capnography and pulse oximetry were performed immediately prior to the start of testing. The transcutaneous CO2 and SpO2 values obtained just prior to provision of the gas mixture were considered the baseline values.
Testing Procedures: Study participants underwent a standard 20 minute HCT and if eligible (i.e. not positive or test not terminated) then immediately continued on to complete the 120 minute extended HCT. A gas mixture of 15% oxygen in nitrogen from a specially prepared cylinder was administered via a non-rebreather mask sealed to the face. Flow was adjusted for patient comfort, and to match inspiratory flow by maintaining non-rebreather bag inflation thus ensuring no entrainment of room air (between 6-15 L/minute). The patient would breathe this mixture for up to 120 minutes, or until they met stopping criteria. Continuous pulse oximetry, transcutaneous capnography and respiratory rate were recorded throughout the HCT. Patients were asked to indicate the severity of dyspnea every 10 minutes using the modified Borg scale. Capillary blood gases were drawn at the end of the standard and prolonged HCTs (i.e. immediately after 20 and 120 minutes, respectively). The patient was observed for 20 minutes after completion of the HCT, or until oxygen saturation and transcutaneous pCO2 returned to baseline levels. The HCT was considered positive and the test was stopped if any of the following occurred: i) oxygen saturation \<88% for two consecutive minutes (as per institutional cutoff for prescription of oxygen); ii) ≥ 10mmHg rise from baseline in transcutaneous CO2 sustained for 2 minutes and confirmed by capillary blood gas; iii) severe symptoms such as dyspnea or confusion; iv) or participant request to stop testing. Repeat complete vital signs were performed prior to the end of the study visit.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will breath in 15% oxygen for 2 hours
Drug: 15% oxygen
Participants will inhale 15% oxygen for 2 hours to see how it affects them.
Prolonged high altitude simulation test
To determine if a prolonged high altitude simulation test (HAST) lasting two hours, identifies more patients at risk of respiratory failure than the standard HAST lasting 20 minutes, in patients with NMD and severe pulmonary restriction
Time frame: 3 years
Interventional high altitude simulation test
In patients with a positive standard or prolonged HAST, we will evaluate the safety of supplemental oxygen administered during a HAST for this population
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in Apr 2018, 24 months.
Of 75 non-industry interventional studies with no phase under Neuromuscular Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 24 months is below that.
Counting every sponsor, half of 84 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxygen
The Hospital for Sick Children →