Actively Recruiting
SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnea - An Explorative Study
Led by Zealand University Hospital · Updated on 2024-12-02
15
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
U
UNEEG Medical A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring a new brainwave monitoring device to better understand the relationship between sleep and wakefulness as a marker for excessive daytime sleepiness in people with severe obstructive sleep apnea (OSA). This study focuses on patients referred for CPAP treatment who experience severe daytime sleepiness, aiming to gather detailed brain activity data that may help identify sleepiness patterns and how CPAP treatment affects these patterns. Participants will undergo an initial in-depth sleep assessment using polysomnography (PSG) and a Multiple Sleep Latency Test (MSLT) to confirm sleep apnea and measure daytime sleepiness. Following these tests, a small EEG electrode device called 24/7 EEG™ SubQ will be implanted under local anesthesia to monitor brain activity continuously for 12 weeks. CPAP treatment will start around the 6-week point after implantation. Two additional home PSG studies will be performed during this period, and the EEG device will be removed at the end of the 12 weeks. Throughout the study, participants will keep a sleep diary, complete daily questionnaires about fatigue, and perform brief cognitive tests on a smartphone or tablet. They may also participate in interviews and wear a motion-tracking watch to monitor activity. Researchers will assess sleepiness using EEG data, sleepiness scales, and cognitive performance tests over approximately four months from enrollment to study completion, while monitoring safety and any adverse effects related to the implant and procedures.
CONDITIONS
Brief Title
SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with severe obstructive sleep apnea (AHI > 30)
- Have not started any positive airway pressure (PAP) treatment
- Epworth Sleepiness Scale (ESS) score above 10 at the time of inclusion
You will not qualify if you...
- Known severe neurological or psychiatric diseases
- Known congestive heart failure, chronic renal failure, liver failure, malignancy, or severe pulmonary disease
- Considerable use of alcohol
- Medication that may influence sleep/wake regulation affecting data quality
- Presence of cochlear implants
- Use of medical devices delivering electrical energy near the implant area
- High risk of surgical complications such as active infection or bleeding disorders
- Unable to operate the device system properly due to mental or physical impairment or lack of assistance
- Infection at the site of device implantation
- Operating MRI scanners
- Profession or hobby with extreme pressure variations (e.g., diving or parachute jumping) except diving/snorkeling up to 5 meters
- Profession or hobby with high risk of trauma to the device or implant area (e.g., martial arts or boxing)
- Other diseases or conditions judged to impact sleep and data quality
- Inability to understand participant instructions or complete the study
- Pregnancy or intention to become pregnant within 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telephone) to check inclusion and exclusion criteria and record medical history
Duration - 1 week after screening
Participants undergo overnight polysomnography (PSG) and multiple sleep latency test (MSLT) to confirm eligibility and assess baseline sleepiness.
1 visit with overnight home PSG followed by daytime MSLT
Duration - Single day with 10 days healing period
Participants receive surgical implantation of the 24/7 EEG™ SubQ device to enable ultra-long-term EEG recording.
1 in-person surgical visit for implantation plus follow-up visit 8-12 days later for suture removal and device setup
Duration - 12 weeks
Participants wear the 24/7 EEG™ SubQ device continuously for up to 12 weeks to record sleep patterns and complete daily sleep diaries, sleepiness scores, and cognitive tests.
Regular visits including PSG assessments at weeks 1-6 and 7-12 during this period; daily self-reporting and cognitive testing at home
Duration - From week 6 to week 12 post-implantation
Participants start continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea approximately 6 weeks after device implantation while continuing EEG monitoring and assessments.
1 visit to start CPAP treatment and device download at 6 weeks; continued daily home assessments
Duration - 2 weeks after treatment completion
Participants have the EEG device explanted and attend a final follow-up visit to assess outcomes and monitor for any adverse effects.
1 visit for device explantation and 1 visit 7-10 days later for suture removal and final assessments
Trial Site Locations
Total: 1 location
1
Zealand University Hospital
Koege, Regional Zealand, Denmark, 4600
Actively Recruiting
Research Team
M
Mathias Sarkez-Knudsen, MD
P
Preben Homøe, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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