Covid19SHYCOVNCT04647747
Silent Hypoxia and Awake Proning in COVID-19 Patients
A study testing Self measurement with pulse oximeter in people with Covid19 and Hypoxemia, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Self measurement with pulse oximeter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 30 Nov 2020to 30 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non dyspneic (NRS =/< 1) patients with positive SARS-CoV-2 test
- Age 18 - 80 years
- Patients managed at home
Who cannot join
- Chronic hypoxia (SpO2 < 93 %) and/or first measured SpO2 < 93 %
- Admitted to hospital for COVID-19 prior to inclusion
- Unable to perform pulse oximetry
- Unable to perform physiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting
The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.
- Being tested
- Self measurement with pulse oximeter
- Keywords
- Silent Hypoxia, Lung Physiotherapy, Home Monitoring
- Medical subject headings
- COVID-19, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self measurement with pulse oximeterOther
Also called Lung physiotherapy
Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists
| Study group | Role | What they receive |
|---|---|---|
| Self measurement of peripheral saturation | Other | Participant will be equipped with a pulse oximeter and perform saturation measurements. Receives: Other: Self measurement with pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who manage to perform daily measurements of SpO2
Measured: January 30, 2021
Incidence rate of silent hypoxia in non-hospitalized COVID-19
Measured: January 30, 2021
Association between silent hypoxia and other subjective and objective measurements of disease severity
Measured: January 30, 2021
Secondary outcomes (5)
Effect of a self-managed physiotherapy program on alleviating hypoxia
Measured: January 30, 2021
Rate of persistent silent hypoxia episode per patients
Measured: January 30, 2021
Rate of silent hypoxia episode per patients
Measured: January 30, 2021
Rate of hospital admission and ICU admission
Measured: January 30, 2021
Incidence of thromboembolic event in outpatients diagnosed with COVID-19
Measured: January 30, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start30 Nov 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
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 Covid19Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Joakim Myklebust-Hansen, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647747
- Sponsor's protocol ID
- SHYCOV2020
- Acronym
- SHYCOV
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2020
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myklebust-Hansen HJ, Hasvik E, Solyga VM, Ghanima W. The feasibility of self-performing measurements of peripheral oxygen saturation and respiratory exercises in home-isolated COVID-19 patients-a single-arm prospective trial. Pilot Feasibility Stud. 2023 Dec 2;9(1):195. doi: 10.1186/s40814-023-01415-x.
PubMed 38042811
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting
- ClinicalTrials.gov ID
- NCT04647747
- Acronym / sponsor ID
- SHYCOV / SHYCOV2020
- Keywords
- Silent Hypoxia, Lung Physiotherapy, Home Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 Dec 2020 (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 Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self measurement of peripheral saturation | Other | Other: Self measurement with pulse oximeterParticipant will be equipped with a pulse oximeter and perform saturation measurements. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non dyspneic (NRS =/< 1) patients with positive SARS-CoV-2 test
- Age 18 - 80 years
- Patients managed at home
Key exclusion criteria (4 listed)
- Chronic hypoxia (SpO2 < 93 %) and/or first measured SpO2 < 93 %
- Admitted to hospital for COVID-19 prior to inclusion
- Unable to perform pulse oximetry
- Unable to perform physiotherapy
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 |
|---|---|---|
| Self measurement with pulse oximeterAlso: Lung physiotherapyParticipant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists | Other | Self measurement of peripheral saturation |
Primary outcome
Number of patients who manage to perform daily measurements of SpO2
Time frame: January 30, 2021
Incidence rate of silent hypoxia in non-hospitalized COVID-19
Time frame: January 30, 2021
Association between silent hypoxia and other subjective and objective measurements of disease severity
Time frame: January 30, 2021
5 secondary outcomes
Effect of a self-managed physiotherapy program on alleviating hypoxia
Time frame: January 30, 2021
Rate of persistent silent hypoxia episode per patients
Time frame: January 30, 2021
Rate of silent hypoxia episode per patients
Time frame: January 30, 2021
Rate of hospital admission and ICU admission
Time frame: January 30, 2021
Incidence of thromboembolic event in outpatients diagnosed with COVID-19
Time frame: January 30, 2021
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 18 Mar 2024.
- Derived from this study: PubMed 38042811Myklebust-Hansen HJ, Hasvik E, Solyga VM, Ghanima W. The feasibility of self-performing measurements of peripheral oxygen saturation and respiratory exercises in home-isolated COVID-19 patients-a single-arm prospective trial. Pilot Feasibility Stud. 2023 Dec 2;9(1):195. doi: 10.1186/s40814-023-01415-x.
- 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. 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?
A study testing Self measurement with pulse oximeter in people with Covid19 and Hypoxemia, run by Ostfold Hospital Trust at 1 site in Norway.
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: finished, as of the sponsor's last update on 18 Mar 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 Norway. 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?
Number of patients who manage to perform daily measurements of SpO2 (time frame: January 30, 2021). The study lists 3 primary outcomes in all. 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 NCT04647747, 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 18 Mar 2024.