Post-COVID-19NCT05124548
Sleep Characteristics in Post-COVID-19 Patients
An observational study of Post-COVID-19, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
After acute infection, patients with coronavirus disease 2019 (COVID-19) often suffer from persisting symptoms for more than 3 months (post COVID-19). Sleep disorders (31%) have already been assessed by questionnaires and interviews in post-COVID-19, but have not yet been proven by polysomnography (PSG), the gold… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-COVID-19
- What is being tested?
- Sleep diagnostics
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2021to 29 Nov 2022
- Phase
- Observational
- 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 50 years
- All sexes
- Adult
Study population: 30 patients will be included in this study. Patients with Post-COVID-19 (n=15) are characterized by Symptoms usually starting 3 months following the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis than SARS-CoV-2 infection. Healthy controls are characterized by having no history of SARS-CoV-2 infection.
Who may be able to join
- Post-COVID-19 Group:
- Patients after SARS-CoV-2 infection with signs of Post-COVID-19
- ≥18 years
- written informed consent
- Healthy controls:
- No history of SARS-CoV-2 infection
- ≥18 years
- written informed consent
Who cannot join
- Post-COVID-19 Group:
- Diagnosis of a breathing-related sleep disorder before SARS-CoV-2 infection
- BMI >25kg/m2
- Healthy controls:
- Diagnosis of a breathing-related sleep disorder
- BMI >25kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Characteristics in Post-Corona Virus Disease 2019 Patients Compared to Healthy Controls - An Observational Trial
After acute infection, patients with coronavirus disease 2019 (COVID-19) often suffer from persisting symptoms for more than 3 months (post COVID-19). Sleep disorders (31%) have already been assessed by questionnaires and interviews in post-COVID-19, but have not yet been proven by polysomnography (PSG), the gold standard for sleep testing. This study aimed to measure sleep characteristics in post-COVID-19 patients.
Read the detailed description
Hypothesis: We hypothesize that post-COVID-19 patients have a significantly higher apnea-hypopnea index (AHI) during sleep compared to healthy controls.
15 post-COVID-19 patients and 15 healthy controls will perform a baseline assessment on day 1 including a 1-minute sit-to-stand test (STST), post-COVID functional scale (PCFS), Ordinal Scale for Clinical Improvement (OSCI), history of COVID-19, social anamnesis, Pittsburgh Sleep Questionnaire and subjective limitations of sleep.
On day 4, after an initialization phase for WHOOP strap (a digital fitness and health coach), all patients performed a single night sleep assessment in a sleep lab via Polysomnography and WHOOP.
- Conditions
- Post-COVID-19
- Being tested
- Sleep diagnostics
- Keywords
- SARS-CoV-2 infection, REM sleep, Chronic fatigue, Whoop strap, Polysomnography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep diagnosticsDiagnostic test
On study day 4, all participants perform a single night sleep assessment in a sleep lab via Polysomnography (PSG) and WHOOP strap, a digital Fitness and health Coach.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID condition | Not described Receives: Diagnostic Test: Sleep diagnostics | |
| Healthy controls | Not described Receives: Diagnostic Test: Sleep diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea-Index (AHI)
Number of apnea or hypopnea Events per hour of sleep
Measured: One single night on study day 4
Secondary outcomes (7)
Rapid Eye Movement (REM) sleep phase
Duration of REM sleep Phase (minutes)
Measured: One single night on study day 4
Deep sleep phase
Duration of deep sleep Phase (minutes)
Measured: One single night on study day 4
Light sleep phase
Duration of light sleep Phase (minutes)
Measured: One single night on study day 4
Periodic leg movement Index
Number of Periodic leg movements per hour of sleep
Measured: One single night on study day 4
Obstructive apnea
Number of obstructive apnea Events per night
Measured: One single night on study day 4
Central apnea
Number of central apnea Events per night
Measured: One single night on study day 4
Mixed apnea
Number of mixed apnea Events per night
Measured: One single night on study day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start25 Nov 2021
- Primary completion28 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124548
- Sponsor's protocol ID
- WHOOP Sleep
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2021
- Last updated
- 30 Nov 2022
- 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Characteristics in Post-Corona Virus Disease 2019 Patients Compared to Healthy Controls - An Observational Trial
- ClinicalTrials.gov ID
- NCT05124548
- Acronym / sponsor ID
- WHOOP Sleep
- Conditions
- Post-COVID-19
- Keywords
- SARS-CoV-2 infection, REM sleep, Chronic fatigue, Whoop strap, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 18 Nov 2021 (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.
After acute infection, patients with coronavirus disease 2019 (COVID-19) often suffer from persisting symptoms for more than 3 months (post COVID-19). Sleep disorders (31%) have already been assessed by questionnaires and interviews in post-COVID-19, but have not yet been proven by polysomnography (PSG), the gold standard for sleep testing. This study aimed to measure sleep characteristics in post-COVID-19 patients.
Detailed description
Hypothesis: We hypothesize that post-COVID-19 patients have a significantly higher apnea-hypopnea index (AHI) during sleep compared to healthy controls.
15 post-COVID-19 patients and 15 healthy controls will perform a baseline assessment on day 1 including a 1-minute sit-to-stand test (STST), post-COVID functional scale (PCFS), Ordinal Scale for Clinical Improvement (OSCI), history of COVID-19, social anamnesis, Pittsburgh Sleep Questionnaire and subjective limitations of sleep.
On day 4, after an initialization phase for WHOOP strap (a digital fitness and health coach), all patients performed a single night sleep assessment in a sleep lab via Polysomnography and WHOOP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID condition | – | Diagnostic Test: Sleep diagnostics |
| Healthy controls | – | Diagnostic Test: Sleep diagnostics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- 30 patients will be included in this study. Patients with Post-COVID-19 (n=15) are characterized by Symptoms usually starting 3 months following the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis than SARS-CoV-2 infection. Healthy controls are characterized by having no history of SARS-CoV-2 infection.
Key inclusion criteria (8 listed)
- Patients after SARS-CoV-2 infection with signs of Post-COVID-19
- ≥18 years
- written informed consent
- No history of SARS-CoV-2 infection
- ≥18 years
Key exclusion criteria (6 listed)
- Diagnosis of a breathing-related sleep disorder before SARS-CoV-2 infection
- BMI >25kg/m2
- Diagnosis of a breathing-related sleep disorder
- BMI >25kg/m2
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 |
|---|---|---|
| Sleep diagnosticsOn study day 4, all participants perform a single night sleep assessment in a sleep lab via Polysomnography (PSG) and WHOOP strap, a digital Fitness and health Coach. | Diagnostic test | Healthy controls, Post-COVID condition |
Primary outcome
Apnea-Hypopnea-Index (AHI)
Time frame: One single night on study day 4
Number of apnea or hypopnea Events per hour of sleep
7 secondary outcomes
Rapid Eye Movement (REM) sleep phase
Time frame: One single night on study day 4
Deep sleep phase
Time frame: One single night on study day 4
Light sleep phase
Time frame: One single night on study day 4
Periodic leg movement Index
Time frame: One single night on study day 4
Obstructive apnea
Time frame: One single night on study day 4
Central apnea
Time frame: One single night on study day 4
Mixed apnea
Time frame: One single night on study day 4
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 30 Nov 2022.
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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 Post-COVID-19, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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 8 inclusion and 6 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 30 Nov 2022. 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 Germany. 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?
Apnea-Hypopnea-Index (AHI) (time frame: One single night on study day 4). 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 30 Nov 2022; AzTrials last refreshed its copy on 2 Nov 2026.