DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMS

NCT06488027 | Completed

• 1 other identifier: DAO-SLEEP-2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.

Conditions

Insomnia; Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• number of patients with insomnia symptoms and DAO deficiency

  number (absolute and percentage) of patients with insomnia symptoms and DAO deficiency

  at the time of enrollment

Study Arms (1)

Patients with insomnia symptoms

Patients with insomnia symptoms visiting AdSalutem sleep center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with insomnia symptoms attending AdSalutem sleep center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AB Biotek: lead

Study Sites (1)

AdSalutem Sleep Institute

Barcelona, Barcelona, 08008, Spain

Location

Related Publications (4)

• 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.

  PMID: 30836736 BACKGROUND

• 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.

  PMID: 17826755 BACKGROUND

• 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.

  PMID: 17700358 BACKGROUND

• 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.

  PMID: 39200725 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Julia Ferrer Garcia, MSc

  AdSalutem Sleep Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: May 5, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: According to legislation

Locations

ES (1)