Obstructive Sleep ApneaNCT06152692
Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to 31 Dec 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Seeking a sleep study using a cardio-respiratory polygraph study
- Having spherical refraction between -5D and 3D, cylinder correction <2D, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle
Who cannot join
- Presence of severe drowsiness or risk profession that requires urgent treatment with CPAP
- Any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery.
- Glaucoma patients will be excluded at the start of the study.
- When both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and glaucoma.
OBJECTIVES: 1. To study the PIO and its fluctuations in patients with SAHS before starting treatment with CPAP. Objective 2. To assess the effect of CPAP on circadian IOP patterns. 3. Evaluate the effect of changes in IOP in patients with OSA treated with CPAP in the nerve fiber layer of the retina.
METHODS: A prospective study to be monitored continuously for 24 hours IOP by contact lens device Sensimed Triggerfish (Sensimed AG, Switzerland). Objective 1. To monitore and compare the IOP for 24 hours at 74 patients diagnosed with SAHS before starting treatment with CPAP and 37 patients without OSA. Objective 2. To study the impact of CPAP treatment by a study design in two stages CPAP / sham CPAP. A first monitoring of IOP will be compared before starting treatment with CPAP, with monitoring a month (CPAP-sham CPAP) and 12 months after initiation of treatment with CPAP. Objective 3. To correlate the values obtained from the monitoring of IOP in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with CPAP.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SHAM Continuous positive airway pressure, Continuous positive airway pressure
- Keywords
- Obstructive Sleep Apnea, Circadian rhythms, Intraocular pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAM Continuous positive airway pressureDevice
Also called SHAM CPAP
Placebo treatment
Continuous positive airway pressureDevice
Also called CPAP
Continuous positive airway pressure treatment for patients randomized to CPAP treatment group
| Study group | Role | What they receive |
|---|---|---|
| OSA + CPAP | Experimental | OSA + CPAP Receives: Device: Continuous positive airway pressure |
| OSA + sham CPAP | Placebo comparator | OSA + sham CPAP Receives: Device: SHAM Continuous positive airway pressure |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythms
Compare the circadian rhythms of continuously measured intraocular pressure for 24 hours between patients diagnosed with OSA before initiating CPAP treatment and a group of subjects without OSA.
Measured: At baseline and 12 months
Circadian intraocular pressure patterns
Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP.
Measured: At baseline, 1 month and 12 months
IOP-followed patterns
Correlate IOP-followed patterns for 24 hours in OSA patients with changes in retinal nerve fiber layer thickness from the start of the study and after 12 months of follow-up.
Measured: At baseline and 12 months
Secondary outcomes (2)
Circadian rhythms
Correlate circadian rhythms followed by IOP as well as changes in the retinal nerve fiber layer with cardio-respiratory polygraphic variables to detect possible risk factors for glaucoma among the OSA population.
Measured: At baseline and 12 months
OSA and lax eyelid syndrome (SPL)
Analyze whether OSA patients who also have lax eyelid syndrome (SPL) have higher or more fluctuating intraocular pressure values that help explain the higher prevalence of glaucoma among patients with OSA and SPL.
Measured: At baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study startJan 2016
- Primary completionJun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152692
- Sponsor's protocol ID
- PI15/02179
- Status last verified
- May 2024
- First submitted
- 21 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Intraocular Pressure Patterns in Patients With Sleep Apnea Syndrome and Treatment With Continuous Air Pressure
- ClinicalTrials.gov ID
- NCT06152692
- Acronym / sponsor ID
- PI15/02179
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Circadian rhythms, Intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Dec 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 purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (SAHS) syndrome and treatment with continuous air pressure (CPAP) on the circadian intraocular pressure (IOP) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between SAHS and glaucoma.
OBJECTIVES: 1. To study the PIO and its fluctuations in patients with SAHS before starting treatment with CPAP. Objective 2. To assess the effect of CPAP on circadian IOP patterns. 3. Evaluate the effect of changes in IOP in patients with OSA treated with CPAP in the nerve fiber layer of the retina.
METHODS: A prospective study to be monitored continuously for 24 hours IOP by contact lens device Sensimed Triggerfish (Sensimed AG, Switzerland). Objective 1. To monitore and compare the IOP for 24 hours at 74 patients diagnosed with SAHS before starting treatment with CPAP and 37 patients without OSA. Objective 2. To study the impact of CPAP treatment by a study design in two stages CPAP / sham CPAP. A first monitoring of IOP will be compared before starting treatment with CPAP, with monitoring a month (CPAP-sham CPAP) and 12 months after initiation of treatment with CPAP. Objective 3. To correlate the values obtained from the monitoring of IOP in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with CPAP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSA + CPAP | Experimental | Device: Continuous positive airway pressureOSA + CPAP |
| OSA + sham CPAP | Placebo comparator | Device: SHAM Continuous positive airway pressureOSA + sham CPAP |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Seeking a sleep study using a cardio-respiratory polygraph study
- Having spherical refraction between -5D and 3D, cylinder correction <2D, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle
Key exclusion criteria (4 listed)
- Presence of severe drowsiness or risk profession that requires urgent treatment with CPAP
- Any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery.
- Glaucoma patients will be excluded at the start of the study.
- When both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.
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 |
|---|---|---|
| SHAM Continuous positive airway pressureAlso: SHAM CPAPPlacebo treatment | Device | OSA + sham CPAP |
| Continuous positive airway pressureAlso: CPAPContinuous positive airway pressure treatment for patients randomized to CPAP treatment group | Device | OSA + CPAP |
Primary outcome
Circadian rhythms
Time frame: At baseline and 12 months
Compare the circadian rhythms of continuously measured intraocular pressure for 24 hours between patients diagnosed with OSA before initiating CPAP treatment and a group of subjects without OSA.
Circadian intraocular pressure patterns
Time frame: At baseline, 1 month and 12 months
Evaluate the effect of CPAP on circadian intraocular pressure patterns after one month and 12 months after starting OSA treatment with CPAP.
IOP-followed patterns
Time frame: At baseline and 12 months
Correlate IOP-followed patterns for 24 hours in OSA patients with changes in retinal nerve fiber layer thickness from the start of the study and after 12 months of follow-up.
2 secondary outcomes
Circadian rhythms
Time frame: At baseline and 12 months
OSA and lax eyelid syndrome (SPL)
Time frame: At baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian rhythms (time frame: At baseline and 12 months). The study lists 3 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 8 May 2024.