Exploring a Biomarker for Daytime Sleepiness in Severe Sleep Apnea

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

This study is testing a new brainwave monitoring device to see if it can help understand why people with severe sleep apnea feel excessively sleepy during the day.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zealand University Hospital (Academic / other)
• Locations: 1 site (Koege, Regional Zealand)
• Trial ID: NCT06711159 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the relationship between sleep-wake patterns and excessive daytime sleepiness (EDS) in patients with severe obstructive sleep apnea (OSA) using a novel brainwave monitoring device. Participants will undergo an initial sleep assessment through polysomnography and a Multiple Sleep Latency Test to evaluate their sleep structure and daytime sleepiness. The study will record ultra-long-term EEG data for six weeks prior to starting CPAP treatment, providing insights into the underlying mechanisms of EDS in OSA patients. The goal is to enhance understanding of sleep disorders and potentially identify biomarkers for EDS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with severe obstructive sleep apnea and experiencing significant daytime sleepiness.

Not a fit: Patients with severe neurological or psychiatric diseases, or those with other significant health issues that could affect sleep regulation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from excessive daytime sleepiness due to obstructive sleep apnea.

How similar studies have performed: While the approach of using ultra-long-term EEG monitoring is innovative, similar studies have shown promise in understanding sleep disorders, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

For a subject to be eligible, all inclusion criteria must be answered "yes":

1. Age ≥18 years
2. Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI \> 30) and have not yet started any form of PAP (positive airway pressure) treatment.
3. ESS score must be above 10 at the time of inclusion.

Exclusion Criteria:

For a subject to be eligible, all exclusion criteria must be answered "no":

1. Known severe neurological or psychiatric diseases.
2. Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.
3. Considerable use of alcohol.
4. Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised.
5. Has cochlear implants.
6. Involved in therapies with medical devices that deliver electrical energy into the area around the implant.
7. Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.
8. Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
9. Has an infection at the site of device implantation.
10. Operates MRI scanners.
11. 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.
12. 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).
13. Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
14. Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
15. Pregnancy or intention to become pregnant within the next 12 months.

Where this trial is running

Koege, Regional Zealand

• Zealand University Hospital — Koege, Regional Zealand, Denmark (Recruiting)

Study contacts

• Principal investigator: Preben Homøe, Professor — Zealand University Hospital, Department of Otorhinolaryngology
• Study coordinator: Mathias Sarkez-Knudsen, MD

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