Sleep Apnea Syndrome, ObstructiveNCT05911737
Ocular Parameters in Patients With Sleep Apnea
An observational study of Sleep Apnea Syndrome, Obstructive and Drowsiness, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire) Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndrome, Obstructive, Drowsiness, Blinking
- What is being tested?
- Short video and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2022to 1 Jul 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with obstructive sleep apnea and controls (not diagnosed with οbstructive sleep apnea)
Who may be able to join
- patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.
Who cannot join
- (dUVA) <5/10,
- intraocular pressure lowering medications
- former corneal or fundus disease
- neurological or psychiatric conditions
- mental disability
- difficulty reading
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Democritus University of Thrace
Alexandroupoli, Evros, 68100
Georgios Labiris, MD, PhD, 00302551030990, labiris@usa.net
About this study
Official title: Ocular Parameters Assessment With a Deep Neural Network in Patients With Sleep Apnea
The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)
Read the detailed description
This is a single-center prospective comparative observational study. One hundred patients with drowsiness that will be examined in the Sleep Clinic of Alexandroupolis University Hospital, aged between18-70 years old, with Distance Uncorrected Visual Acuity ≥ (dUVA): 5/10 will be recruited. They will be separated into two groups, one consisting of patients with diagnosed Obstructive Sleep Apnea and one without this diagnosis, according to the Epworth Sleepiness Scale - ESS, which is a valid tool for quantifying daily sleepiness. A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented to them and a questionnaire will follow to assess the level of concentration during the video (the subtitles are crucial to understanding the video's plot). The video will be displayed in a 11.6" screen with resolution of 1920x1080 pixels, at 70 cm patient-to-screen distance. The patients' eyes will be recorded during the video with a Raspberry Pi Camera Module IR-CUT v2 (5MP,1080p) with 2 IR LED lights, connected to a Raspberry Pi 3 model v1.2, operating at the original resolution of 1080×1920, at 20 cm patient-to-camera distance and an algorithm will be developed to analyze the following parameters: 1. The complete and incomplete blinks defined by the "length of palpebral fissure-to-iris diameter" ratio, 3. Length of palpebral fissure of both eyes.
- Conditions
- Sleep Apnea Syndrome, Obstructive, Drowsiness, Blinking, Concentration Ability Impaired, Pupil Diameter
- Being tested
- Short video and Questionnaire
- Keywords
- Reading Time, Fixation, Saccadic movements, Eyelid margin distance
- Medical subject headings
- Sleep Apnea, Obstructive, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short video and QuestionnaireBehavioural
A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented and a questionnaire will follow to assess the level of concentration during the video
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Obstructive Sleep Apnea | Patients diagnosed with Obstructive Sleep Apnea Receives: Behavioral: Short video and Questionnaire | |
| Patients not diagnosed with Obstructive Sleep Apnea | Patients not diagnosed with Obstructive Sleep Apnea Receives: Behavioral: Short video and Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of blinks during the 10-minute video
The total number of blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Measured: 1 week
Total number of complete blinks during the 10-minute video
The total number of complete blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Measured: 1 week
Total number of incomplete blinks during the 10-minute video
The total number of incomplete blinks during the 10-minute video. Incomplete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Measured: 1 week
Number of total blinks for each minute
Number of total blinks for each minute of the 10-minute video
Measured: 1 week
Number of complete blinks for each minute
Number of complete blinks for each minute of the 10-minute video
Measured: 1 week
Number of incomplete blinks for each minute
Number of incomplete blinks per minute for each minute of the 10-minute video
Measured: 1 week
Total blinks per minute
Total blinks per minute during the 10-minute video
Measured: 1 week
Complete blinks per minute
Complete blinks per minute during the 10-minute video
Measured: 1 week
Incomplete blinks per minute
Incomplete blinks per minute during the 10-minute video
Measured: 1 week
Length of palpebral fissure of both eyes
The distance between the upper eyelid margin and the lower eyelid margin (ie. the vertical dimension of the palpebral fissure) for each frame
Measured: 1 week
Secondary outcomes (5)
Fixations to the area of interest
Number of fixations to the area of interest (subtitles)
Measured: 1 week
Fixation duration
Mean fixation duration (duration of fixation per video per participant)
Measured: 1 week
Reading time
The absolute reading time (the sum of the duration of all fixations and saccadic movements in the area of focus starting from the first fixation)
Measured: 1 week
Participant's dedication time to the area of focus
The percentage of time that each participant dedicates to the area of focus depending on the time of subtitle exposure (eg. subtitle reading time/overall subtitle exposure= 2500 msec/3000 msec=83%)
Measured: 1 week
Rereadings
Rereadings: the number of fixations/seccadic movements to the area of focus after the first reading (indicating of subtitlte interpretation difficulty or extended subtitle exposure time).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndrome, ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911737
- Sponsor's protocol ID
- ES2/Th35/27-02-2020
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Parameters Assessment With a Deep Neural Network in Patients With Sleep Apnea
- ClinicalTrials.gov ID
- NCT05911737
- Acronym / sponsor ID
- ES2/Th35/27-02-2020
- Conditions
- Sleep Apnea Syndrome, Obstructive, Drowsiness, Blinking, Concentration Ability Impaired, Pupil Diameter
- Keywords
- Reading Time, Fixation, Saccadic movements, Eyelid margin distance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)
Detailed description
This is a single-center prospective comparative observational study. One hundred patients with drowsiness that will be examined in the Sleep Clinic of Alexandroupolis University Hospital, aged between18-70 years old, with Distance Uncorrected Visual Acuity ≥ (dUVA): 5/10 will be recruited. They will be separated into two groups, one consisting of patients with diagnosed Obstructive Sleep Apnea and one without this diagnosis, according to the Epworth Sleepiness Scale - ESS, which is a valid tool for quantifying daily sleepiness. A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented to them and a questionnaire will follow to assess the level of concentration during the video (the subtitles are crucial to understanding the video's plot). The video will be displayed in a 11.6" screen with resolution of 1920x1080 pixels, at 70 cm patient-to-screen distance. The patients' eyes will be recorded during the video with a Raspberry Pi Camera Module IR-CUT v2 (5MP,1080p) with 2 IR LED lights, connected to a Raspberry Pi 3 model v1.2, operating at the original resolution of 1080×1920, at 20 cm patient-to-camera distance and an algorithm will be developed to analyze the following parameters: 1. The complete and incomplete blinks defined by the "length of palpebral fissure-to-iris diameter" ratio, 3. Length of palpebral fissure of both eyes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Obstructive Sleep Apnea | – | Behavioral: Short video and QuestionnairePatients diagnosed with Obstructive Sleep Apnea |
| Patients not diagnosed with Obstructive Sleep Apnea | – | Behavioral: Short video and QuestionnairePatients not diagnosed with Obstructive Sleep Apnea |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with obstructive sleep apnea and controls (not diagnosed with οbstructive sleep apnea)
Key inclusion criteria (1 listed)
- patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.
Key exclusion criteria (6 listed)
- (dUVA) <5/10,
- intraocular pressure lowering medications
- former corneal or fundus disease
- neurological or psychiatric conditions
- mental disability
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 |
|---|---|---|
| Short video and QuestionnaireA 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented and a questionnaire will follow to assess the level of concentration during the video | Behavioural | Patients diagnosed with Obstructive Sleep Apnea, Patients not diagnosed with Obstructive Sleep Apnea |
Primary outcome
Total number of blinks during the 10-minute video
Time frame: 1 week
The total number of blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Total number of complete blinks during the 10-minute video
Time frame: 1 week
The total number of complete blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Total number of incomplete blinks during the 10-minute video
Time frame: 1 week
The total number of incomplete blinks during the 10-minute video. Incomplete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Number of total blinks for each minute
Time frame: 1 week
Number of total blinks for each minute of the 10-minute video
Number of complete blinks for each minute
Time frame: 1 week
Number of complete blinks for each minute of the 10-minute video
Number of incomplete blinks for each minute
Time frame: 1 week
Number of incomplete blinks per minute for each minute of the 10-minute video
Total blinks per minute
Time frame: 1 week
Total blinks per minute during the 10-minute video
Complete blinks per minute
Time frame: 1 week
Complete blinks per minute during the 10-minute video
Incomplete blinks per minute
Time frame: 1 week
Incomplete blinks per minute during the 10-minute video
Length of palpebral fissure of both eyes
Time frame: 1 week
The distance between the upper eyelid margin and the lower eyelid margin (ie. the vertical dimension of the palpebral fissure) for each frame
5 secondary outcomes
Fixations to the area of interest
Time frame: 1 week
Fixation duration
Time frame: 1 week
Reading time
Time frame: 1 week
Participant's dedication time to the area of focus
Time frame: 1 week
Rereadings
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Georgios Labiris, MD, PhD study chair
Democritus University of Thrace
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 Sleep Apnea Syndrome, Obstructive and Drowsiness, run by Democritus University of Thrace at 1 site in Greece.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Labiris, MD, PhD (2551030405 ext. 0030, labiris@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of blinks during the 10-minute video (time frame: 1 week). The study lists 10 primary outcomes in all. 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 22 Jun 2023.