SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study

NCT06711159 | Recruiting

• 1 other identifier: EMN-2021-06803
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Study aim: This study aims to use a new brainwave monitoring device that meassure brainwaves 24 hours a day to create better understanding of sleep-wake interplay as a biomarker for excessive daytime sleepiness because of obstructive sleep apnea. Study Method, Design, and Procedures Patients with sleep apnea referred to the Sleep Clinic at the Department of Ear, Nose, Throat, and Jaw Surgery in Køge for CPAP treatment, who also experience severe daytime sleepiness, will be offered participation in this study. The goal is for 15 participants to complete the entire protocol. Procedure Overview Initial Sleep Assessment: The study begins with an in-depth sleep assessment through polysomnography (PSG) followed by a Multiple Sleep Latency Test (MSLT). PSG: This sleep study evaluates sleep structure, confirms sleep apnea, and rules out other sleep disorders. MSLT: This test measures the brain's tendency to fall asleep during the day. Additional Home-Based Sleep Studies: Participants will undergo two more PSG studies in their homes. EEG Monitoring: After the initial assessments, participants will have a small EEG electrode implanted to monitor brain activity. The implant, a CE-certified device called 24/7 EEG™ SubQ, will be inserted under local anesthesia by an experienced surgeon. Once post-surgery swelling subsides (after about 7-10 days), continuous EEG monitoring will begin, where participants connect an external data storage device during the day. The device records for 12 weeks, and CPAP treatment begins around the 6-week mark. After 12 weeks, the EEG device is removed, and the study ends. Aditional Data Collection (Optional) During the 12 weeks of EEG recording, participants are asked to report: Sleep Diary: Log daytime sleep episodes, including planned naps and unintended naps. Questionnaires and Tests: Complete daily questionnaires about fatigue symptoms and perform a brief attention and reaction test. These tasks take 3-10 minutes each day and are accessible via smartphone or tablet. Interviews and Movement Tracking: Participants may also be invited to interviews on how sleepiness affects their daily life and asked to wear a motion-tracking watch to monitor activity.

Conditions

Obstructive Sleep Apnea (OSA); Excessive Daytime Sleepiness

Keywords

Excessive daytime sleepiness; Ultra long-term EEG; Obstructive Sleep Apnea; CPAP

Outcome Measures

Primary Outcomes (2)

• Ultra long-term EEG derived sleepiness biomarker

  Our primary explorative objective is to scrutinize subcutaneous Ultra Long-term EEG for potential biomarkers predicting sleepiness in OSA patients. Determining daytime wake-to-sleep transition rate, episodes of microsleep, and episodes of macro sleep, alongside the duration and patterns of these events. Our explorative findings will be correlated and preliminary validated against the well-established sleepiness metrics and questionnaires, multiple sleep latency test (MSLT), Epworth Sleepiness scale (ESS), Karolinska Sleepiness Scale (KSS), and a 3-minute psycomotor vigilance tast test (PVT), as well as to the patient's experience of falling asleep or dozing off intentionally and unintentionally in the form of a "sleep and nap diary". Any potential sleepiness biomarker derived from this study will be available for future confirmatory trials.

  From enrollment to completion 4 months

• The effects of CPAP treatment on ultra long-term EEG

  Our experimental objective is to determine the effects of CPAP treatment on sleep quality, quantity, and timing from the day-to-day perspective that ULT-EEG provides. Furthermore, the experimental design enables us to clinically validate the exploratively deduced sleepiness biomarker candidates through comparisons before and after the intervention of CPAP treatment conditions. Previous studies on the effect of CPAP on sleepiness reduction have shown a dose-dependent configuration with CPAP usage. ESS is typically reduced by 4,78 (or more). We expect relevant biomarker candidates to follow similar patterns when CPAP is introduced in a population with severe OSA and EDS.

  From enrollment to completion 4 months

Secondary Outcomes (1)

• Validate automatic sleep/wake classification from ultra long-term EEG for patients with severe obstructive sleep apnea

  From enrollment to completion 4 months

Interventions

continuous positive airway pressure DEVICE

Initiation of treatment with continuous positive airway pressure for obstructive sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for this study are patients who suffer from Excessive Daytime Sleepiness (defined by an epworth sleepiness scale above 10 at inclussion) because of untreated Obstructive Sleep Apnoea (OSA) and with the inclusion/exclusion criteria listed below to ensure generalizability of study and to minimize the influence of other contributors to EDS.

You may qualify if:

• Age ≥18 years
• Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI \> 30) and have not yet started any form of PAP (positive airway pressure) treatment.

You may not qualify if:

• Known severe neurological or psychiatric diseases.
• Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.
• Considerable use of alcohol.
• Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised.
• Has cochlear implants.
• Involved in therapies with medical devices that deliver electrical energy into the area around the implant.
• Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.
• Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
• Has an infection at the site of device implantation.
• Operates MRI scanners.
• Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 metres depth.
• Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
• Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
• Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
• Pregnancy or intention to become pregnant within the next 12 months.

Sponsors & Collaborators

• Zealand University Hospital: lead
• UNEEG Medical A/S: collaborator
• T&W Engineering A/S: collaborator

Study Sites (1)

Zealand University Hospital

Koege, Regional Zealand, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Preben Homøe, Professor

  Zealand University Hospital, Department of Otorhinolaryngology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Sarkez-Knudsen, MD

CONTACT

+4521250736; mrkn@regionsjaelland.dk

Preben Homøe, Professor

CONTACT

+45 40879765; prho@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 2, 2024
• Study Start: October 11, 2024
• Primary Completion: October 11, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-10

Locations

DK (1)