Bipolar DisorderCISNCT06504342
Clocks in Sync - Circadian Rhythm and Bipolar Mania
A study testing Blue-blocking glasses, Time-restricted eating and Lightly tinted glasses in people with Bipolar Disorder and Mania, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- Blue-blocking glasses, Time-restricted eating and Lightly tinted glasses
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2024to 2 Oct 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be over age 16
- Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
- Be willing to have investigators obtain information from the treatment team and electronic medical record
- Participants must be able to read and understand English or French.
- Be willing and able to provide informed consent.
Who cannot join
- Have a history of eating disorders.
- Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
- Have a neurocognitive disorder
- Take hypoglycemia-inducing medications
- Be pregnant/lactating women
- Have a diagnosis of sleep apnea
- Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.
Read the detailed description
This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation.
The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims:
Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining.
Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial.
Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- Blue-blocking glasses, Time-restricted eating, Lightly tinted glasses
- Keywords
- Chronotherapy, Blue-blocking glasses, Time-restricted eating
- Medical subject headings
- Bipolar Disorder, Mania, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue-blocking glassesDevice
These lenses will filter ~10% of visible light across the visible light range (including in the range activating melanopsin) with complete blockade of ultraviolet light.
Time-restricted eatingBehavioural
Avoid caloric food intake for a fourteen-hour period overnight from 6 p.m. to 8 a.m
Lightly tinted glassesDevice
These lenses block shorter wavelengths of light, mainly ultraviolet light.
| Study group | Role | What they receive |
|---|---|---|
| Blue-blocking glasses and time-restricted eating | Experimental | Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am. Receives: Device: Blue-blocking glasses; Behavioral: Time-restricted eating |
| Blue-blocking glasses and no time-restricted eating | Active comparator | Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am. Receives: Device: Blue-blocking glasses |
| Lightly tinted glasses and time-restricted eating | Active comparator | Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am. Receives: Behavioral: Time-restricted eating; Device: Lightly tinted glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Time-Restricted Eating: 1) Study Participation
Feasibility of time restricted eating for inpatients with mania as assessed by study participation, defined as the ratio of patients who consent to participate in the study after being approached by the research team. This will be reported as a ratio with the number of participants who consented as the numerator and the total number of patients approached for participation in the study as the denominator.
Measured: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.
Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Feasibility of time restricted eating for inpatients with mania as assessed by self-reported and observed adherence. At each study visit, the research team will consider the participants' self-report, notes in the medical record, and their own observations to select a rating on a Likert scale indicating how closely the participant has adhered to the schedule of their assigned intervention(s): a) Fully adherent; b) Almost fully adherent; c) Mostly adherent; d) Half adherent; e) Mostly non-adherent; f) Barely adherent; g) Not adherent.
Measured: Baseline to Week 2 or until discharge, whichever comes first
Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
Feasibility of time restricted eating for inpatients with mania as assessed by qualitative semi-structured interview. The research team will conduct a semi-structured interview with participants to elicit their perspective on the feasibility of time restricted eating in the context of an inpatient research study.
Measured: One interview prior to the participant's discharge, at the end of their participation in the study.
Secondary outcomes (8)
Change in the Young Mania Rating Scale
The Young Mania Rating Scale is used to evaluate the severity of manic symptoms at baseline and over time in individuals with mania. It is an 11-item scale and total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Measured: Baseline to Week 2 or until discharge, whichever comes first
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
The Montgomery-Åsberg Depression Rating Scale is a clinician-rated depression scale used to assess depression symptom severity. It consists of 10 scored items, each scaled from 0 to 6 and the entire form totaling 0 to 60. The higher the score, the more severe the symptoms. A total score of 0-8 = remission/symptoms absent; 9-17 = mild depression; 18-34 = moderate depression; 35-60 = severe depression
Measured: Baseline to Week 2 or until discharge, whichever comes first
Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)
Self-reported measurement of the severity of anxiety symptoms experienced within the last two weeks. It consists of 7 scored items and one follow-up question. Each of the 7 scored items generates a value from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0 to 21, with higher scores indicating more severe symptoms of anxiety. These scores are interpreted in the following manner: a score of 0-4 indicates little or no anxiety, a score of 5-9 indicates mild anxiety, a score of 10-14 indicates moderate anxiety, and a score of 15-21 indicates severe anxiety. Generally, a score of 10 or above is considered to be a clinical cutoff implying that the respondent may be suffering from a general anxiety disorder.
Measured: Baseline to Week 2 or until discharge, whichever comes first
Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)
This questionnaire has 19 questions, each with a number of points. Scores can range from 16-86. Scores of 41 and below indicate "evening types." Scores of 59 and above indicate "morning types." Scores between 42-58 indicate "intermediate types."
Measured: Baseline; Week 1; Week 2 or until discharge, whichever comes first
Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)
The Pittsburg Sleep Quality Index Questionnaire is self-administered questionnaire designed to evaluate sleep quality consisting of 18 items that in turn are comprised of seven components, which include subjective sleep quality, sleep duration, sleep onset, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. Each weighted equally on a 0-3 scale to be summed to yield a global PSQI score, which ranges between 0 and 21, where the higher the scores, the worse the sleep quality.
Measured: Baseline; Week 1; Week 2 or until discharge, whichever comes first
Change in Circadian Rhythms: 1) Actigraphy
Wrist actigraphy data that captures the participant's activity level and their exposure to ambient light. The participant will wear the device continuously for one week. The research team will compare the data from different days to assess any changes in activity or light exposure.
Measured: One week of continuous wearing starting at the Baseline visit.
Change in Circadian Rhythms: 2) Heart Rate
Heart rate monitors will be used to capture data from two different 24-hour periods one week apart. The research team will compare the two time periods for each participant to determine if there are changes.
Measured: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
Change in Circadian Rhythms: 3) Body Temperature
Body temperature monitoring using a device attached to the skin of the abdomen near the navel. The device will capture temperature data for two 24-hour periods one week apart. The research team will compare the two time periods for each participant to determine if there are changes.
Measured: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start17 Sep 2024
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Randomised
- Intervention model
- Factorial
- Model description
- 2 by 2 factorial design. Only 3 of the 4 arms will be implemented, with the double control arm not implemented in the pilot.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jess G Fiedorowicz, MD, PHD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504342
- Sponsor's protocol ID
- 20240219-01H
- Acronym
- CIS
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06504342
- Acronym / sponsor ID
- CIS / 20240219-01H
- Conditions
- Bipolar Disorder, Mania
- Keywords
- Chronotherapy, Blue-blocking glasses, Time-restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 16 Jul 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 sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.
Detailed description
This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation.
The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims:
Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining.
Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial.
Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 2 by 2 factorial design. Only 3 of the 4 arms will be implemented, with the double control arm not implemented in the pilot.
| Arm | Type | Receives |
|---|---|---|
| Blue-blocking glasses and time-restricted eating | Experimental | Device: Blue-blocking glasses, Behavioral: Time-restricted eatingParticipants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am. |
| Blue-blocking glasses and no time-restricted eating | Active comparator | Device: Blue-blocking glassesParticipants will only be wearing the experimental blue-blocking glasses from 6pm-8am. |
| Lightly tinted glasses and time-restricted eating | Active comparator | Behavioral: Time-restricted eating, Device: Lightly tinted glassesParticipants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Be over age 16
- Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
- Be willing to have investigators obtain information from the treatment team and electronic medical record
- Participants must be able to read and understand English or French.
- Be willing and able to provide informed consent.
Key exclusion criteria (7 listed)
- Have a history of eating disorders.
- Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
- Have a neurocognitive disorder
- Take hypoglycemia-inducing medications
- Be pregnant/lactating women
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 |
|---|---|---|
| Blue-blocking glassesThese lenses will filter ~10% of visible light across the visible light range (including in the range activating melanopsin) with complete blockade of ultraviolet light. | Device | Blue-blocking glasses and no time-restricted eating, Blue-blocking glasses and time-restricted eating |
| Time-restricted eatingAvoid caloric food intake for a fourteen-hour period overnight from 6 p.m. to 8 a.m | Behavioural | Blue-blocking glasses and time-restricted eating, Lightly tinted glasses and time-restricted eating |
| Lightly tinted glassesThese lenses block shorter wavelengths of light, mainly ultraviolet light. | Device | Lightly tinted glasses and time-restricted eating |
Primary outcome
Feasibility of Time-Restricted Eating: 1) Study Participation
Time frame: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.
Feasibility of time restricted eating for inpatients with mania as assessed by study participation, defined as the ratio of patients who consent to participate in the study after being approached by the research team. This will be reported as a ratio with the number of participants who consented as the numerator and the total number of patients approached for participation in the study as the denominator.
Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Time frame: Baseline to Week 2 or until discharge, whichever comes first
Feasibility of time restricted eating for inpatients with mania as assessed by self-reported and observed adherence. At each study visit, the research team will consider the participants' self-report, notes in the medical record, and their own observations to select a rating on a Likert scale indicating how closely the participant has adhered to the schedule of their assigned intervention(s): a) Fully adherent; b) Almost fully adherent; c) Mostly adherent; d) Half adherent; e) Mostly non-adherent; f) Barely adherent; g) Not adherent.
Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
Time frame: One interview prior to the participant's discharge, at the end of their participation in the study.
Feasibility of time restricted eating for inpatients with mania as assessed by qualitative semi-structured interview. The research team will conduct a semi-structured interview with participants to elicit their perspective on the feasibility of time restricted eating in the context of an inpatient research study.
8 secondary outcomes
Change in the Young Mania Rating Scale
Time frame: Baseline to Week 2 or until discharge, whichever comes first
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Time frame: Baseline to Week 2 or until discharge, whichever comes first
Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)
Time frame: Baseline to Week 2 or until discharge, whichever comes first
Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)
Time frame: Baseline; Week 1; Week 2 or until discharge, whichever comes first
Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)
Time frame: Baseline; Week 1; Week 2 or until discharge, whichever comes first
Change in Circadian Rhythms: 1) Actigraphy
Time frame: One week of continuous wearing starting at the Baseline visit.
Change in Circadian Rhythms: 2) Heart Rate
Time frame: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
Change in Circadian Rhythms: 3) Body Temperature
Time frame: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
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 18 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.
Jess G Fiedorowicz, MD, PHD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue-blocking glasses, Time-restricted eating and Lightly tinted glasses in people with Bipolar Disorder and Mania, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 inclusion and 7 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 18 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 1 site in Canada. 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?
Feasibility of Time-Restricted Eating: 1) Study Participation (time frame: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.). The study lists 3 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 18 Feb 2026.