Insomnia ChronicNCT06550388
Subjective Sleep Quality of Patients With Chronic Insomnia
A study testing Nutritional Education and Physical Activity in people with Insomnia Chronic, run by Mayo Clinic at 2 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Nutritional Education and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Insomnia
- 18-70 years of age
Who cannot join
- Known untreated sleep disorder
- Cardiovascular diagnosis that would not allow safe increase of physical activity
- Diabetes
- Pregnancy or lactation
- Current use of a vegan diet or Mediterranean diet
- BMI ≤ 22
Show all 9Show fewer
- Score higher than 15 on PHQ-8
- Diagnosed with a severe neurological or sensory impairment that would significant impact participation
- Currently performing shift work/diagnosis of a circadian rhythm disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: Effect of Brief Lifestyle Interventions on the Subjective Sleep Quality of Patients With Chronic Insomnia
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)
Read the detailed description
Chronic insomnia disorder is highly prevalent, occurring in 4% to 22% of the population in the U.S. The consequences of chronic insomnia are significant including mood disorders, work-related and motor vehicle accidents, and overall poor quality of life. Lack of sleep satisfaction, a hallmark of chronic insomnia, is associated with metabolic syndrome, diabetes, hypertension, coronary heart disease and depression1.
Chronic insomnia is predominantly managed with hypnotics and other medications despite the effectiveness of and patient preference for CBT-I. The American College of Physicians (ACP) and the American Academy of Sleep Medicine (AASM) guidelines for management of chronic insomnia recommend all patients receive Cognitive Behavioral Therapy for Insomnia (CBT-I) as first line treatment for chronic insomnia2,3. CBT-I is a structured, nonpharmacological treatment that uses educational, cognitive, and behavioral strategies. Meta-analyses have shown CBT-I is consistently associated with improved sleep quality in chronic insomnia with or without comorbidities4,5. While the strategies associated with CBT-I have been found to be effective for the management of chronic insomnia, lifestyle intervention to improve patients' diet and physical activity is not part of traditional CBT-I. The field of behavioral sleep medicine can expand interventional strategies to promote health and well-being while also optimizing sleep health.
A pathway to improve sleep health is a shift from a typical medicine perspective which emphasizes identification and treatment of symptoms, to a health promotion perspective, which emphasizes the promotion of overall well-being. Incorporating principles from lifestyle medicine and behavioral sleep medicine can both identify and treat sleep disorders plus promote overall health including education regarding diet quality and exercise. Targeting diet quality and physical activity education within the context of CBT-I will underscore the importance of nonpharmacological treatment and the promotion of health and well-being which is central to behavioral sleep and lifestyle medicine.
The etiology of chronic insomnia disorder is multifactorial with research supporting poor diet and lack of physical activity as contributing factors to poor sleep. Previous studies have reported higher diet quality promotes better sleep quality and mental health. Sleep deprivation and sleep disturbances have been linked to poor diet quality. Eating too quickly or skipping meals, overabundant meals, irregular mealtimes, and poor food quality, all are dietary causes of sleep disorders. Additionally, the timing of meals, including frequency and regularity of snacks, may desynchronize circadian rhythm, affect metabolism, and favor obesity6. There is mounting evidence suggesting sleep influences dietary choices as well. Individuals who sleep less are more likely to prefer energy-rich foods (e.g., fats and refined carbohydrates), eat fewer vegetables, and choose irregular eating patterns7.
Additionally, several pathways have been proposed regarding benefits of the Mediterranean diet and healthy dietary patterns on sleep, including the role of the gut microbiome8, inflammation and the consumption of dietary tryptophan and melatonin9. Some observational studies have shown a high intake of fruit and vegetables is associated with better sleep quality and lower risk of insomnia while a cohort study of older adults in Spain showed that higher consumption of red meat was associated with poor sleep quality and snoring10,11.
Recent studies have also highlighted the importance of physical activity and the impact on sleep quality. Low levels of physical activity have been reported as significant risk factors for both prevalent and incident insomnia12. One study documented improvements in sleep after days with more acute moderate-intensity activity in patients diagnosed with chronic insomnia13. Physical activity and sleep likely influence each other in both physiological and psychological pathways. For example, in older adults, increasing physical activity has been shown to improve excessive daytime sleepiness and reduce prevalence of insomnia symptoms14. Although there have been studies assessing the association between sleep quality and physical activity, very little has looked at patients diagnosed with chronic insomnia and we believe this is the first study to add a brief lifestyle intervention to traditional CBT-I.
There is support for the inclusion of healthy diet education and increased physical activity in interventions programs, such as CBT-I, to improve sleep quality among individuals diagnosed with chronic insomnia. Combining health promoting behaviors in conjunction with CBT-I is likely to be of great importance in preventing a large set of chronic non-communicable disease. At the very least, the combination of traditional CBT-I with healthy diet education and physical education may increase sleep quality, diet quality and physical activity for patients diagnosed with chronic insomnia.
- Conditions
- Insomnia Chronic
- Being tested
- Nutritional Education, Physical Activity
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional EducationBehavioural
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.
Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Education | Other | 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. Receives: Behavioral: Physical Activity |
| Nutritional Education | Other | 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. Receives: Behavioral: Nutritional Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality measured by the Pittsburgh Sleep Quality Index
Measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Measured: Baseline, 84 days
Secondary outcomes (1)
Change in insomnia measured by the Insomnia Severity Index
Self-reported insomnia severity index questionnaire score, using a total score, scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe)
Measured: Baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexa Kane, Mayo Clinic
- Investigators
- Alexa Kane, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550388
- Sponsor's protocol ID
- 24-004753
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brief Lifestyle Interventions on the Subjective Sleep Quality of Patients With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT06550388
- Acronym / sponsor ID
- 24-004753
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Chronic insomnia disorder is highly prevalent, occurring in 4% to 22% of the population in the U.S. The consequences of chronic insomnia are significant including mood disorders, work-related and motor vehicle accidents, and overall poor quality of life. Lack of sleep satisfaction, a hallmark of chronic insomnia, is associated with metabolic syndrome, diabetes, hypertension, coronary heart disease and depression1.
Chronic insomnia is predominantly managed with hypnotics and other medications despite the effectiveness of and patient preference for CBT-I. The American College of Physicians (ACP) and the American Academy of Sleep Medicine (AASM) guidelines for management of chronic insomnia recommend all patients receive Cognitive Behavioral Therapy for Insomnia (CBT-I) as first line treatment for chronic insomnia2,3. CBT-I is a structured, nonpharmacological treatment that uses educational, cognitive, and behavioral strategies. Meta-analyses have shown CBT-I is consistently associated with improved sleep quality in chronic insomnia with or without comorbidities4,5. While the strategies associated with CBT-I have been found to be effective for the management of chronic insomnia, lifestyle intervention to improve patients' diet and physical activity is not part of traditional CBT-I. The field of behavioral sleep medicine can expand interventional strategies to promote health and well-being while also optimizing sleep health.
A pathway to improve sleep health is a shift from a typical medicine perspective which emphasizes identification and treatment of symptoms, to a health promotion perspective, which emphasizes the promotion of overall well-being. Incorporating principles from lifestyle medicine and behavioral sleep medicine can both identify and treat sleep disorders plus promote overall health including education regarding diet quality and exercise. Targeting diet quality and physical activity education within the context of CBT-I will underscore the importance of nonpharmacological treatment and the promotion of health and well-being which is central to behavioral sleep and lifestyle medicine.
The etiology of chronic insomnia disorder is multifactorial with research supporting poor diet and lack of physical activity as contributing factors to poor sleep. Previous studies have reported higher diet quality promotes better sleep quality and mental health. Sleep deprivation and sleep disturbances have been linked to poor diet quality. Eating too quickly or skipping meals, overabundant meals, irregular mealtimes, and poor food quality, all are dietary causes of sleep disorders. Additionally, the timing of meals, including frequency and regularity of snacks, may desynchronize circadian rhythm, affect metabolism, and favor obesity6. There is mounting evidence suggesting sleep influences dietary choices as well. Individuals who sleep less are more likely to prefer energy-rich foods (e.g., fats and refined carbohydrates), eat fewer vegetables, and choose irregular eating patterns7.
Additionally, several pathways have been proposed regarding benefits of the Mediterranean diet and healthy dietary patterns on sleep, including the role of the gut microbiome8, inflammation and the consumption of dietary tryptophan and melatonin9. Some observational studies have shown a high intake of fruit and vegetables is associated with better sleep quality and lower risk of insomnia while a cohort study of older adults in Spain showed that higher consumption of red meat was associated with poor sleep quality and snoring10,11.
Recent studies have also highlighted the importance of physical activity and the impact on sleep quality. Low levels of physical activity have been reported as significant risk factors for both prevalent and incident insomnia12. One study documented improvements in sleep after days with more acute moderate-intensity activity in patients diagnosed with chronic insomnia13. Physical activity and sleep likely influence each other in both physiological and psychological pathways. For example, in older adults, increasing physical activity has been shown to improve excessive daytime sleepiness and reduce prevalence of insomnia symptoms14. Although there have been studies assessing the association between sleep quality and physical activity, very little has looked at patients diagnosed with chronic insomnia and we believe this is the first study to add a brief lifestyle intervention to traditional CBT-I.
There is support for the inclusion of healthy diet education and increased physical activity in interventions programs, such as CBT-I, to improve sleep quality among individuals diagnosed with chronic insomnia. Combining health promoting behaviors in conjunction with CBT-I is likely to be of great importance in preventing a large set of chronic non-communicable disease. At the very least, the combination of traditional CBT-I with healthy diet education and physical education may increase sleep quality, diet quality and physical activity for patients diagnosed with chronic insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Education | Other | Behavioral: Physical ActivityIn 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. |
| Nutritional Education | Other | Behavioral: Nutritional EducationIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Chronic Insomnia
- 18-70 years of age
Key exclusion criteria (9 listed)
- Known untreated sleep disorder
- Cardiovascular diagnosis that would not allow safe increase of physical activity
- Diabetes
- Pregnancy or lactation
- Current use of a vegan diet or Mediterranean diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional EducationIn 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. | Behavioural | Nutritional Education |
| Physical ActivityIn 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. | Behavioural | Physical Activity Education |
Primary outcome
Change in sleep quality measured by the Pittsburgh Sleep Quality Index
Time frame: Baseline, 84 days
Measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
1 secondary outcome
Change in insomnia measured by the Insomnia Severity Index
Time frame: Baseline, 14 days, 28 days, 42 days, 56 days, 70 days, 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexa Kane principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Education and Physical Activity in people with Insomnia Chronic, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (time frame: Baseline, 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.