Sleep ApneaHYPNOSANCT06514482
Spanish Registry of Patients With Sleep Apnea and Daytime Sleepiness
An observational study of Sleep Apnea, run by Hospital San Pedro de Logroño at 1 site in Spain.
Trial summary
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Diagnosis
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2022to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred to the sleep unit with suspected obstructive sleep apnea dream.
Who may be able to join
- Patients who come to the sleep consultation for sleep study results for suspected OSA.
- Patients older than 18 years.
- Signature of the informed consent.
Who cannot join
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.
- Patients with > 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).
- A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.
- Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history).
- Any process, cardiovascular or not, that limits life expectancy to less than one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital San Pedro
Logroño, La Rioja, 26006
Jorge Lazaro, 636920584, jlazaro@riojasalud.es
Alejandra Roncero, 677151261, aroncerol@riojasalud.es
About this study
Official title: Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.
OSA patients will be evaluated at baseline, 6, 12, and 24 months.
- Conditions
- Sleep Apnea
- Being tested
- Diagnosis
- Keywords
- CPAP, residual sleepiness, OSA
- Medical subject headings
- Sleep Apnea Syndromes, Microcephaly, Primary Autosomal Recessive, 6, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosisDiagnostic test
Diagnosis
| Study group | Role | What they receive |
|---|---|---|
| NO OSA | Control group Receives: Diagnostic Test: Diagnosis | |
| OSA WHITH CPAP | Not described Receives: Diagnostic Test: Diagnosis | |
| OSA WHITHOUT CPAP | Not described Receives: Diagnostic Test: Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Data analysis of the AHI in the respiratory polygraphy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start28 Oct 2022
- Primary completion30 May 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital San Pedro de Logroño
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514482
- Sponsor's protocol ID
- PI 569
- Acronym
- HYPNOSA
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roncero A, Mediano O, Cano-Pumarega I, Barbe F, Lopez-Picado A, Sanchez-de-la-Torre M. HYPNOSA: Study protocol for a prospective observational cohort of patients with obstructive sleep apnea. Sleep Med. 2026 Nov;147:109115. doi: 10.1016/j.sleep.2026.109115. Epub 2026 Jul 8.
PubMed 42435507
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna
- ClinicalTrials.gov ID
- NCT06514482
- Acronym / sponsor ID
- HYPNOSA / PI 569
- Conditions
- Sleep Apnea
- Keywords
- CPAP, residual sleepiness, OSA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital San Pedro de LogroñoUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jul 2024 (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.
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.
OSA patients will be evaluated at baseline, 6, 12, and 24 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NO OSA | – | Diagnostic Test: DiagnosisControl group |
| OSA WHITH CPAP | – | Diagnostic Test: Diagnosis |
| OSA WHITHOUT CPAP | – | Diagnostic Test: Diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the sleep unit with suspected obstructive sleep apnea dream.
Key inclusion criteria (3 listed)
- Patients who come to the sleep consultation for sleep study results for suspected OSA.
- Patients older than 18 years.
- Signature of the informed consent.
Key exclusion criteria (6 listed)
- Psycho-physical inability to complete questionnaires.
- Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.
- Patients with > 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).
- A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.
- Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history).
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 |
|---|---|---|
| DiagnosisDiagnosis | Diagnostic test | NO OSA, OSA WHITH CPAP, OSA WHITHOUT CPAP |
Primary outcome
Primary Outcome
Time frame: 6 months
Data analysis of the AHI in the respiratory polygraphy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42435507Roncero A, Mediano O, Cano-Pumarega I, Barbe F, Lopez-Picado A, Sanchez-de-la-Torre M. HYPNOSA: Study protocol for a prospective observational cohort of patients with obstructive sleep apnea. Sleep Med. 2026 Nov;147:109115. doi: 10.1016/j.sleep.2026.109115. Epub 2026 Jul 8.
- Individual participant dataSharing planned: Undecided
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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.
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, run by Hospital San Pedro de Logroño 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 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Lazaro (636920584, jlazaro@riojasalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514482, which also lists 1 linked publication.
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 17 Feb 2026.