Subjective Sleep Quality of Patients With Chronic Insomnia
Key facts
- Who runs it
- Mayo Clinic
- Where
- Jacksonville, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 5 people enrolled
- Started
- 10 Sept 2024
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Nutritional Education
- Physical Activity
- Record updated
- 13 February 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Diagnosis of Chronic Insomnia
- 18-70 years of age
Who cannot take part
- Known untreated sleep disorder
- Diabetes
- Diagnosed with a severe neurological or sensory impairment that would significant impact participation
- Currently performing shift work/diagnosis of a circadian rhythm disorder
- Cardiovascular diagnosis that would not allow safe increase of physical activity
- Pregnancy or lactation
- Current use of a vegan diet or Mediterranean diet
- BMI ≤ 22
- Score higher than 15 on PHQ-8
Where in United States
- Mayo ClinicJacksonville, United StatesNo longer taking part
- Mayo Clinic in FloridaJacksonville, United StatesNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to assess subjective sleep quality, diet quality, physical activity in patients with chronic insomnia before and after a brief lifestyle intervention during a traditional course of Cognitive Behavioral Therapy for Insomnia (CBT-I)
The 2 groups in the trial
- Physical Activity EducationOther group
In addition to the traditional course of CBT-I, the PI will recommend patient to increase physical activity minutes per week. The increase in physical activity will be based on patient's current level of physical activity.
Treatment: Physical Activity
- Nutritional EducationOther group
In addition to the traditional course of CBT-I, the PI will provide education and materials regarding the Mediterranean Diet. Patient will be provided with the Mayo Clinic booklet on Mediterranean Diet and asked to increase their daily intake in two categories assessed by the Mini-EAT.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Brief Lifestyle Interventions on the Subjective Sleep Quality of Patients With Chronic Insomnia
- Record updated
- 13 February 2026