Sleep Characteristics in Post-COVID-19 Patients

Completed

• Conditions: Post-COVID-19
• Interventions: Diagnostic Test: Sleep diagnostics

• Registration Number: NCT05124548
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief 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 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 Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-18
• Study Start: 2021-11-25
• Status Verified: 2022-11
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-29
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-COVID condition	Sleep diagnostics	-
Healthy controls	Sleep diagnostics	-

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea-Index (AHI)	One single night on study day 4	Number of apnea or hypopnea Events per hour of sleep

Secondary Outcome Measures

Name	Time	Method
Mixed apnea	One single night on study day 4	Number of mixed apnea Events per night
Light sleep phase	One single night on study day 4	Duration of light sleep Phase (minutes)
Periodic leg movement Index	One single night on study day 4	Number of Periodic leg movements per hour of sleep
Obstructive apnea	One single night on study day 4	Number of obstructive apnea Events per night
Central apnea	One single night on study day 4	Number of central apnea Events per night
Rapid Eye Movement (REM) sleep phase	One single night on study day 4	Duration of REM sleep Phase (minutes)
Deep sleep phase	One single night on study day 4	Duration of deep sleep Phase (minutes)

Trial Locations

Locations (1)

Schoen Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany