Can Non-Alcoholic Beer Improve Sleep for Regular Drinkers?

JRCT ID: jRCT1051240185

Registered date:15/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: insomnia disorder
• Date of first enrollment: 15/11/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): The questionnaire will be administered to outpatients (excluding patients for whom the principal investigator is the attending physician). The questionnaire items include the AUDIT and the Pittsburgh Sleep Questionnaire. Patients who meet specific scores on the AUDIT (8 to 19 points) and the Pittsburgh Sleep Questionnaire (6 points or more) will be considered patients with drinking habits and insomnia. Patients who meet all other questionnaire item criteria and who provide research consent will be considered study subjects. The study subjects will then be randomly assigned to two groups, an intervention group and a control group. The primary physicians of the study subjects will not be informed whether the subjects are assigned to the intervention or control group. The principal investigator will provide 24 bottles of non-alcoholic beer to the intervention group only and suggest that they drink one bottle/day every day from after dinner to before bed. The drinking period will last a total of 24 days, even if some days are missed. During the above 24-day period, participants in both groups will complete a daily sleep and drinking diary (a sleep chart for all days and a diary in which the time and amount of non-alcoholic and alcoholic beverages consumed can be entered). The intervention group will keep the above logbooks even on days when they do not consume non-alcoholic beverages; the morning following the end of the 24-day period (Day 25), participants in both groups will complete the Pittsburgh Sleep Questionnaire to complete the study. Participants in both groups will be asked to lead their normal lives except for keeping a sleep and drinking diary.

Outcome(s)

• Primary Outcome: Pittsburgh Sleep Questionnaire scores

Secondary Outcome

sleeping time
regular prescription doses of benzodiazepine sleeping pills
alcohol Consumption Volume

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Patients who have been continuously attending the hospital as outpatients for more than 1 year
Patients who are scheduled to continue regular outpatient visits during the intervention period
Patients with a score of 6 or higher on the Pittsburgh Sleep Questionnaire
Patients who have been taking benzodiazepines for more than 4 weeks
Patients who have a habit of drinking alcohol from after dinner to before bed at least 4 times a week
Patients who have received a full explanation of the study in writing
Patients who have agreed to the research description document

Exclude criteria

Patients who consume non-alcoholic beverages more than twice a month
Patients with a history of liver disease
Patients who are pregnant or lactating at the time of intervention
Patients with a diagnosis of alcohol dependence at the time of intervention or with a history of such diagnosis
Patients with an AUDIT score of 20 or higher
Patients with an AUDIT score of 7 or less
Patients 19 years old or younger
Patients over 75 years old
Patients who cannot respond to the questionnaire
Patients who are deemed inappropriate as research participants by outpatient attending physicians due to their medical conditions, etc

Related Information

• Primary Sponsor: Shima Sunao