OSANCT01672606
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
A study testing Rocuronium in people with OSA and Rocuronium, run by Malin Jonsson Fagerlund at 1 site in Sweden.
Trial summary
This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- OSA, Rocuronium, Neuromuscular Blockade
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Feb 2016
- Phase
- Interventional
- 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 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI <35.
Who cannot join
- If they don´t fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Stockholm, se-17176
About this study
Official title: Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.
This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.
- Conditions
- OSA, Rocuronium, Neuromuscular Blockade, Hypoxic Ventilatory Response, CPAP
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called CPAP
Partial neuromuscular blockade with rocuronium with a TOF 0.70
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Experimental | Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90 Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxic ventilatory response
Measured: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
Secondary outcomes (6)
Hypercarbic ventilatory response
Measured: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
Hypoxic ventilatory response
Measured: At diagnosis and after 3 month of CPAP treatment at home
Hypoxic ventilatory response during acute CPAP treatment
Measured: At diagnosis and after 3 month of CPAP treatment
Hypercarbic ventilatory response
Measured: At diagnosis and after 3 month of CPAP treatment at home
Hypercarbic ventilatory response during acute CPAP treatment
Measured: At diagnosis and after 3 month CPAP treatment at home
Upper airway obstruction
Measured: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malin Jonsson Fagerlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, MD, PhD, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672606
- Sponsor's protocol ID
- OSA ROC
- Status last verified
- Feb 2016
- First submitted
- 1 Jun 2012
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.
- ClinicalTrials.gov ID
- NCT01672606
- Acronym / sponsor ID
- OSA ROC
- Conditions
- OSA, Rocuronium, Neuromuscular Blockade, Hypoxic Ventilatory Response, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Malin Jonsson FagerlundUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Aug 2012 (estimated)
- 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 describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Experimental | Drug: RocuroniumIntravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI <35.
Key exclusion criteria (1 listed)
- If they don´t fit the inclusion criteria
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 |
|---|---|---|
| RocuroniumAlso: CPAPPartial neuromuscular blockade with rocuronium with a TOF 0.70 | Drug | Rocuronium |
Primary outcome
Hypoxic ventilatory response
Time frame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
6 secondary outcomes
Hypercarbic ventilatory response
Time frame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
Hypoxic ventilatory response
Time frame: At diagnosis and after 3 month of CPAP treatment at home
Hypoxic ventilatory response during acute CPAP treatment
Time frame: At diagnosis and after 3 month of CPAP treatment
Hypercarbic ventilatory response
Time frame: At diagnosis and after 3 month of CPAP treatment at home
Hypercarbic ventilatory response during acute CPAP treatment
Time frame: At diagnosis and after 3 month CPAP treatment at home
Upper airway obstruction
Time frame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
Related trials for OSA
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive 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.
Malin Jonsson Fagerlund, MD, PhD principal investigator
Karolinska University Hospital and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium in people with OSA and Rocuronium, run by Malin Jonsson Fagerlund 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypoxic ventilatory response (time frame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home). 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 29 Feb 2016.