DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS

NCT ID: NCT06488027

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-05

Study Completion Date

2023-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Insomnia Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with insomnia symptoms

Patients with insomnia symptoms visiting AdSalutem sleep center

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years old
* With one or more symptoms of insomnia
* Explicit acceptance to participate to the study through informed consent

Exclusion Criteria

* Insomnia symptoms that could be justified by the existance of another sleep pathology (e.g., narcolepsy)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Biotek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Ferrer Garcia, MSc

Role: STUDY_CHAIR

AdSalutem Sleep Institute

Locations

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AdSalutem Sleep Institute

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 30836736 (View on PubMed)

Garcia-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.

Reference Type BACKGROUND
PMID: 17826755 (View on PubMed)

Ayuso 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.

Reference Type BACKGROUND
PMID: 17700358 (View on PubMed)

Lopez 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.

Reference Type DERIVED
PMID: 39200725 (View on PubMed)

Other Identifiers

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DAO-SLEEP-2022

Identifier Type: -

Identifier Source: org_study_id

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