InsomniaNCT06488027
DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS
An observational study of Insomnia and Insomnia Disorder, run by AB Biotek at 1 site in Spain.
Trial summary
Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Insomnia Disorder
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2023to 27 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with insomnia symptoms attending AdSalutem sleep center
Who may be able to join
- Older than 18 years old
- With one or more symptoms of insomnia
- Explicit acceptance to participate to the study through informed consent
Who cannot join
- Insomnia symptoms that could be justified by the existance of another sleep pathology (e.g., narcolepsy)
Trial locations and contacts
1 site in 1 country.
About this study
Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.
- Conditions
- Insomnia, Insomnia Disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with insomnia symptoms | Patients with insomnia symptoms visiting AdSalutem sleep center |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with insomnia symptoms and DAO deficiency
number (absolute and percentage) of patients with insomnia symptoms and DAO deficiency
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start5 May 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Ferrer Garcia, MSc, Study chair, AdSalutem Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488027
- Sponsor's protocol ID
- DAO-SLEEP-2022
- Status last verified
- May 2025
- First submitted
- 28 Jun 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Antropometric data
Publications
Schnedl WJ, Lackner S, Enko D, Schenk M, Holasek SJ, Mangge H. Evaluation of symptoms and symptom combinations in histamine intolerance. Intest Res. 2019 Jul;17(3):427-433. doi: 10.5217/ir.2018.00152. Epub 2019 Mar 7.
PubMed 30836736Garcia-Martin E, Ayuso P, Martinez C, Agundez JA. Improved analytical sensitivity reveals the occurrence of gender-related variability in diamine oxidase enzyme activity in healthy individuals. Clin Biochem. 2007 Nov;40(16-17):1339-41. doi: 10.1016/j.clinbiochem.2007.07.019. Epub 2007 Aug 11.
PubMed 17826755Ayuso P, Garcia-Martin E, Martinez C, Agundez JA. Genetic variability of human diamine oxidase: occurrence of three nonsynonymous polymorphisms and study of their effect on serum enzyme activity. Pharmacogenet Genomics. 2007 Sep;17(9):687-93. doi: 10.1097/FPC.0b013e328012b8e4.
PubMed 17700358Lopez Garcia R, Ferrer-Garcia J, Sansalvador A, Quera-Salva MA. Prevalence of Diamine Oxidase Enzyme (DAO) Deficiency in Subjects with Insomnia-Related Symptoms. J Clin Med. 2024 Aug 6;13(16):4583. doi: 10.3390/jcm13164583.
PubMed 39200725
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS
- ClinicalTrials.gov ID
- NCT06488027
- Acronym / sponsor ID
- DAO-SLEEP-2022
- Conditions
- Insomnia, Insomnia Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AB BiotekIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 5 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.
Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with insomnia symptoms | – | –Patients with insomnia symptoms visiting AdSalutem sleep center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with insomnia symptoms attending AdSalutem sleep center
Key inclusion criteria (3 listed)
- Older than 18 years old
- With one or more symptoms of insomnia
- Explicit acceptance to participate to the study through informed consent
Key exclusion criteria (1 listed)
- Insomnia symptoms that could be justified by the existance of another sleep pathology (e.g., narcolepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with insomnia symptoms and DAO deficiency
Time frame: at the time of enrollment
number (absolute and percentage) of patients with insomnia symptoms and DAO deficiency
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 30 May 2025.
- Background: PubMed 30836736Schnedl WJ, Lackner S, Enko D, Schenk M, Holasek SJ, Mangge H. Evaluation of symptoms and symptom combinations in histamine intolerance. Intest Res. 2019 Jul;17(3):427-433. doi: 10.5217/ir.2018.00152. Epub 2019 Mar 7.
- Background: PubMed 17826755Garcia-Martin E, Ayuso P, Martinez C, Agundez JA. Improved analytical sensitivity reveals the occurrence of gender-related variability in diamine oxidase enzyme activity in healthy individuals. Clin Biochem. 2007 Nov;40(16-17):1339-41. doi: 10.1016/j.clinbiochem.2007.07.019. Epub 2007 Aug 11.
- Background: PubMed 17700358Ayuso P, Garcia-Martin E, Martinez C, Agundez JA. Genetic variability of human diamine oxidase: occurrence of three nonsynonymous polymorphisms and study of their effect on serum enzyme activity. Pharmacogenet Genomics. 2007 Sep;17(9):687-93. doi: 10.1097/FPC.0b013e328012b8e4.
- Derived from this study: PubMed 39200725Lopez Garcia R, Ferrer-Garcia J, Sansalvador A, Quera-Salva MA. Prevalence of Diamine Oxidase Enzyme (DAO) Deficiency in Subjects with Insomnia-Related Symptoms. J Clin Med. 2024 Aug 6;13(16):4583. doi: 10.3390/jcm13164583.
- Individual participant dataSharing planned: Yes. Antropometric data
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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.
Julia Ferrer Garcia, MSc study chair
AdSalutem Sleep Institute
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 Insomnia and Insomnia Disorder, run by AB Biotek 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 1 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 30 May 2025. 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?
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?
number of patients with insomnia symptoms and DAO deficiency (time frame: at the time of enrollment). 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 NCT06488027, which also lists 4 linked publications.
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 30 May 2025.