InsomniaNCT03085446
Insomnia in Older Adults: Impact of Personalized, Diet-Induced Alterations in the Microbiota
A study testing PDM nutritional intervention and General information on nutrition and health in people with Insomnia, run by University of Haifa at 1 site in Israel.
Trial summary
Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression)… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- PDM nutritional intervention and General information on nutrition and health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2017to 1 May 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Based on DSM-5 criteria of diagnosed chronic insomnia in adults, participants will be included if they report difficulties in initiating or maintaining sleep or early morning awakening at least three nights per week that lasts for a minimum of three months, and impaired daytime functioning.
Who cannot join
- Based on standard clinical history questionnaires and sleep questionnaires, participants will be excluded if they are less than 65 years, have any significant visual or hearing impairments or chronic pain, if they have or had significant and unstable medical, neurological, or psychiatric illness, if they are alcohol or drug abusers or taking psychiatric medication, or if they had sleep apnea syndrome (SAS) or periodic limb movement disorder during sleep (PLMD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-armed, Single-blind Randomized Clinical Trial for Older Adults With Insomnia
Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression), functional limitations, and cognitive decline. Available pharmacological and behavioral treatments focusing on reducing nighttime hyper-arousal offer limited success, and it appears that there is no "one size fits all" treatment for late life insomnia. Mounting evidence suggests that sleep is related to metabolic status, however, studies on the associations between sleep and dietary patterns are surprisingly scarce.
The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease and provides the rationale for the present project. Findings demonstrate that gut microbiota modulates mental capacities such as brain plasticity and cognitive functions in older adults, as well as stress related mental illness. The composition of the intestinal microbiota in older people (>65 years) differs from the core microbiota and diversity levels of younger adults. With age, gut populations of beneficial microbes show a marked decline. As diet has been shown to markedly promote microbiota biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel approach for the treatment of mental health. Although insomnia is strongly linked to mental health (e.g., depression and anxiety), as well as cognitive and motor performance, the effects of diet-induced microbiota alterations, based on individual microbiota composition, on late life insomnia is currently unknown.
The proposed project will be the first to investigate the associations between gut microbiota and sleep, and assess the potential of a six-months personalized, diet-induced microbiota alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look at cognitive, motor and mental health factors as possible mediators in this relationship. Specifically, we will test the associations between microbiota composition and sleep quality, both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the impact of PDM on changes in cognitive, motor and mental health functions; and identify the mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM intervention on sleep quality. Findings are expected to improve the quality of life of older adults by enhancing their sleep, functional status, mental health and overall wellbeing.
- Conditions
- Insomnia
- Being tested
- PDM nutritional intervention, General information on nutrition and health
- 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.
PDM nutritional interventionBehavioural
personalized, diet-induced alterations in microbiota (PDM) for six months. (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3).
General information on nutrition and healthBehavioural
General information on nutrition and health for six months: (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3),
| Study group | Role | What they receive |
|---|---|---|
| PDM nutritional intervention | Experimental | Not described Receives: Behavioral: PDM nutritional intervention |
| control | Experimental | General information on nutrition and health Receives: Behavioral: General information on nutrition and health |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISI - Insomnia sevirity Index
Insomnia Severity Index is based on DSM-4 carteria for insomnia surveys will be completed once at all four study waves (T0-T3)
Measured: one year
Actigraphy based Insomnia
Objective sleep measurements: Actigraphy: wrist-worn ambulatory device/ To obtain a composite score for insomnia based on actigraphy, the following cutoff will be used: sleep efficiency<=85%; and sleep onset latency (SOL) and/or wake after sleep onset (WASO) >=30 minutes, at least 3 times per week.
Two- week assessments will be repeated during all four study waves (T0-T3)
Measured: one year
Secondary outcomes (8)
Insomnia by the consensus sleep diary
To obtain a composite score for insomnia based on the consensus sleep diary, the following cutoff will be used: sleep efficiency<=85%; and sleep onset latency (SOL) and/or wake after sleep onset (WASO) >=30 minutes, at least 3 times per week.
Two- week assessments will be repeated during all four study waves (T0-T3)
Measured: one year
Insomnia by the The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over a 1-month time interval. Its composite global score is the sum of 7 subscore domains of sleep quality.
will be completed once at all four study waves (T0-T3)
Measured: one year
Cognitive Functioning
Cognitive performance will be evaluated using the computerized "Cantab connect research" neuropsychological examination for neurocognitive evaluation, which consists of three 20-minute sessions that measure a wide variety of cognitive The Cantab connect research computerized neurocognitive evaluation was specially developed to provide a sensitive test to detect reduction in cognitive functioning among older adults, and it simultaneously provides several measures of cognitive functioning. The software is easy to use and self-explanatory-it guides the user, describes progress rates, and points out areas of difficulty. Assessments will be repeated at all study waves (T0-T3).
Measured: one year
Motor Assessment- Gait
Gait will be evaluated as a composite score based on walking speed and stride variability, as a single task, and together with a cognitive task (e.g., subtraction by 3) as a dual task.
once at all four study waves (T0-T3)
Measured: one year
Motor Assessment- Activity
Daily activity assessment will be based on a composite score of step count and energy expenditure.
once at all four study waves (T0-T3)
Measured: one year
Wellbeing and Mental health status
Wellbeing will be assessed using the World Health Organization Quality of Life short form questionnaire (WhoQOL-BREF). These assessments will be carried out at all study waves (T0-T3).
Measured: one year
Mental health status - Depression
Depression will be assessed using the Geriatric Depression Scale (GDS). These assessments will be carried out at all study waves (T0-T3).
Measured: one year
Mental health status - Anxiety
Anxiety will be assessed using the ZUNG selfrating and anxiety scale These assessments will be carried out at all study waves (T0-T3).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Feb 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- The Max Stern Academic College Of Emek Yezreel, Migal, Galilee Technology Center, Tel Hai College, Clalit Health Services, Technion, Israel Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Tamar Shochat, DSc, Principal investigator, University of HaifaUzi Milman, MD, Principal investigator, ClalitIris Haimov, Professor, Principal investigator, The Max Stern Yezreel Valley CollegeMaayan Agmon, Ph.D, Principal investigator, University of HaifaSnait Tamir, Ph.D, Principal investigator, Migal, Galilee Technology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085446
- Sponsor's protocol ID
- TSHaifa
- Status last verified
- Nov 2020
- First submitted
- 19 Mar 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-armed, Single-blind Randomized Clinical Trial for Older Adults With Insomnia
- ClinicalTrials.gov ID
- NCT03085446
- Acronym / sponsor ID
- TSHaifa
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- The Max Stern Academic College Of Emek Yezreel, Migal, Galilee Technology Center, Tel Hai College, Clalit Health Services, Technion, Israel Institute of Technology
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 21 Mar 2017 (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.
Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression), functional limitations, and cognitive decline. Available pharmacological and behavioral treatments focusing on reducing nighttime hyper-arousal offer limited success, and it appears that there is no "one size fits all" treatment for late life insomnia. Mounting evidence suggests that sleep is related to metabolic status, however, studies on the associations between sleep and dietary patterns are surprisingly scarce.
The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease and provides the rationale for the present project. Findings demonstrate that gut microbiota modulates mental capacities such as brain plasticity and cognitive functions in older adults, as well as stress related mental illness. The composition of the intestinal microbiota in older people (>65 years) differs from the core microbiota and diversity levels of younger adults. With age, gut populations of beneficial microbes show a marked decline. As diet has been shown to markedly promote microbiota biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel approach for the treatment of mental health. Although insomnia is strongly linked to mental health (e.g., depression and anxiety), as well as cognitive and motor performance, the effects of diet-induced microbiota alterations, based on individual microbiota composition, on late life insomnia is currently unknown.
The proposed project will be the first to investigate the associations between gut microbiota and sleep, and assess the potential of a six-months personalized, diet-induced microbiota alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look at cognitive, motor and mental health factors as possible mediators in this relationship. Specifically, we will test the associations between microbiota composition and sleep quality, both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the impact of PDM on changes in cognitive, motor and mental health functions; and identify the mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM intervention on sleep quality. Findings are expected to improve the quality of life of older adults by enhancing their sleep, functional status, mental health and overall wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDM nutritional intervention | Experimental | Behavioral: PDM nutritional intervention |
| control | Experimental | Behavioral: General information on nutrition and healthGeneral information on nutrition and health |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Based on DSM-5 criteria of diagnosed chronic insomnia in adults, participants will be included if they report difficulties in initiating or maintaining sleep or early morning awakening at least three nights per week that lasts for a minimum of three months, and impaired daytime functioning.
Key exclusion criteria (1 listed)
- Based on standard clinical history questionnaires and sleep questionnaires, participants will be excluded if they are less than 65 years, have any significant visual or hearing impairments or chronic pain, if they have or had significant and unstable medical, neurological, or psychiatric illness, if they are alcohol or drug abusers or taking psychiatric medication, or if they had sleep apnea syndrome (SAS) or periodic limb movement disorder during sleep (PLMD).
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 |
|---|---|---|
| PDM nutritional interventionpersonalized, diet-induced alterations in microbiota (PDM) for six months. (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3). | Behavioural | PDM nutritional intervention |
| General information on nutrition and healthGeneral information on nutrition and health for six months: (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3), | Behavioural | control |
Primary outcome
ISI - Insomnia sevirity Index
Time frame: one year
Insomnia Severity Index is based on DSM-4 carteria for insomnia surveys will be completed once at all four study waves (T0-T3)
Actigraphy based Insomnia
Time frame: one year
Objective sleep measurements: Actigraphy: wrist-worn ambulatory device/ To obtain a composite score for insomnia based on actigraphy, the following cutoff will be used: sleep efficiency<=85%; and sleep onset latency (SOL) and/or wake after sleep onset (WASO) >=30 minutes, at least 3 times per week. Two- week assessments will be repeated during all four study waves (T0-T3)
8 secondary outcomes
Insomnia by the consensus sleep diary
Time frame: one year
Insomnia by the The Pittsburgh Sleep Quality Index
Time frame: one year
Cognitive Functioning
Time frame: one year
Motor Assessment- Gait
Time frame: one year
Motor Assessment- Activity
Time frame: one year
Wellbeing and Mental health status
Time frame: one year
Mental health status - Depression
Time frame: one year
Mental health status - Anxiety
Time frame: one year
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 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Tamar Shochat, DSc principal investigator
University of Haifa
Uzi Milman, MD principal investigator
Clalit
Iris Haimov, Professor principal investigator
The Max Stern Yezreel Valley College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDM nutritional intervention and General information on nutrition and health in people with Insomnia, run by University of Haifa at 1 site in Israel.
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 1 inclusion and 1 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
ISI - Insomnia sevirity Index (time frame: one year). The study lists 2 primary outcomes in all. 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 3 Nov 2020.