跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT07027943
NCT07027943已完成不适用

Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms

AB Biotek2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年3月13日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Considering the high prevalence of DAO enzyme deficiency in patients referring insomnia symptoms, it would be plausible that the appearance of insomnia symptoms were explained by the DAO enzyme deficiency.

One of the strategies to revert DAO enzyme deficiency would be to supplement patients with DAO enzyme, helping at recovering the normal DAO levels. Therefore, the objective of the present study is to evaluate the effect of DAO enzyme supplementation on the insomnia symptoms characteristics in patients with insomnia symptoms and genetic DAO deficiency as expected from bearing at least one of the 4 above-mentioned SNPs of the AOC1 gene.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Older than 18 years
  • •With the ability to understand and sign informed consent reviewed and approved by the Grupo Hospitalario Quironsalud-Catalunya.
  • •That refer one or more symptoms of insomnia, these being: Difficulty initiating sleep, Difficulty maintaining sleep, Waking up early with inability to go back to sleep.
  • •Who are carriers, either heterozygous or homozygous, of at least one of the following 4 SNPs associated with a reduction in the enzymatic activity of DAO or a decreased transcriptional activity of it: c.47C>T (rs10156191), c.995C>T (rs1049742), c.1990C>G (rs1049793), c.-691G>T (rs2052129).
  • •With the ability to attend the foreseen face-to-face and telephonic study visits.
  • •With the ability to intake the product under study
  • •Explicit agreement on study participation by reading, understanding, and signing the informed consent reviewed and approved by the Grupo Hospitalario Quironsalud-Catalunya

排除标准

  • •Insomnia symptoms referred by patients that might be explained by other co-morbid sleep disorders, e.g., narcolepsy, circadian rhythm disturbances, parasomnia, etc.
  • •Taking DAO supplementation less than 1 month prior to the start of the study.
  • •Following a diet low in histamine less than 1 month prior to the start of the study.
  • •Volunteers with allergies to some of the ingredients of the product under study.

结局指标

主要结局

Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale

时间窗: Visit day 0, day 7, day 14, day 21 and day 28.

Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 28. A higher score indicates a worse outcome (severity of insomnia).

次要结局

  • Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Pittsburgh Sleep Quality Index (PSQI) scale(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Pittsburgh Sleep Quality Index (PSQI) scale(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who reduce at least one point on Component 2 (Sleep latency) of the Pittsburgh Sleep Quality Index (PSQI) scale(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who reduce at least one point on Component 5 (Sleep disturbance) of the Pittsburgh Sleep Quality Index (PSQI) scale(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who reduce at least one point on Component 7 (Daytime dysfunction) of the Pittsburgh Sleep Quality Index (PSQI) scale(Visit day 0 and day 28.)
  • Serum DAO activity levels(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who increase their serum DAO activity levels(Visit day 0 and day 28.)
  • Mean DAO baseline activity levels(Visit day 0 and day 28.)
  • Mean increase in DAO activity levels(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who improve their symptoms associated with histamine intolerance due to DAO deficiency(Visit day 0 and day 28.)
  • Number (absolute and percentage) of patients who refer improvement in their daytime repercussions of insomnia(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Number (absolute and percentage) of patients in the once-a day groups who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Number (absolute and percentage) of patients in the three times per day groups who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Report of adverse events(Visit day 0, day 7, day 14, day 21 and day 28.)
  • Percentage of doses taken of DAO supplementation(Visit day 0 and day 28.)
  • Percentage of compliant patients(Visit day 0 and day 28.)

研究者

发起方
AB Biotek
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

已完成
不适用
DAO DEFICIENCY SCREENING AMONG PATIENTS WITH INSOMNIA SYMPTOMSInsomnia DisorderInsomnia
NCT06488027AB Biotek200
招募中
1 期
Daridorexant to treat insomnia in patients with mild cognitive impairment and mild to moderate Alzheimer disease.Insomnia DisorderSLEEPAlzheimer DiseaseMedDRA version: 20.0Level: LLTClassification code: 10078083Term: Insomnia disorder Class: 10037175
CTIS2023-503301-10-00niversity Hospital Of Montpellier62
Unknown
不适用
Evaluation in Patients With Obstructive Sleep Apnea That Had Undergone Diagnosis and Surgical TreatmentOSA
NCT02977338Hillel Yaffe Medical Center200
已完成
4 期
Dexmedetomidine Supplemented Analgesia in Patients at High-risk of Obstructive Sleep ApneaObstructive Sleep ApneaAnalgesiaDexmedetomidineHigh-flow Nasal CannulaSleep Quality
NCT04608331Peking University First Hospital152
Unknown
2 期
Sleep Apnea Syndrome and Vitamin DObstructive Sleep Apnea-hypopnea Syndrome
NCT01323218University Hospital, Clermont-Ferrand80