The effectiveness of Melatonin therapy, Circadian Rhythm Correction Training Package in Cardiac Patients

Melatonin therapy, Circadian Rhythm Correction Training Package, and Their Combination for Circadian Realignment in Cardiac Patients: A Four-Arm Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260504069257N1

Enrollment

240

Registered

2026-05-16

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac diseases. Chronic ischemic heart disease, unspecified

Interventions

Intervention 1: Intervention group 1: This group will receive melatonin therapy. Members of this group will take 5 mg of melatonin for two months. They will take the medication one hour before bedtime

removing mobile phones and laptops from the bedroom

limiting blue light (screen light) exposure in the 2 hours before sleep. Modifying pre-sleep behaviors: Avoiding caffeine, nicotine, and stimulants after 4 PM

avoiding heavy exercise or large meals close to bedtime

replacing them with relaxing activities (reading, gentle stretching, breathing exercises).Daytime behaviors: Regular physical activity in the morning or early afternoon

using stress reduction techniques (mindfulness, relaxation).Supplementary materials provided to participants: Sleep hygiene booklet (key points in simple language), daily sleep diary for tracking slee

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Men and women aged 40 to 75 years Received a diagnosis of STEMI or NON-STEMI Physically stable and able to provide informed consent Willing to comply with study procedures and follow-up visits.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To determine the participants' chronotype, the standard version of the Munich ChronoType Questionnaire (MCTQ) will be used. The primary outcome measure is the sleep-corrected midpoint of sleep on work-free days (MSFsc), which serves as the proxy for chronotype and is calculated as MSFsc = MSF – (SDf – SDweek) / 2. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Chronotype is assessed using the MCTQ. The primary measure is MSFsc (midpoint of sleep on work-free days corrected for sleep debt), calculated in hours. Lower MSFsc indicates morningness, higher values indicate eveningness.;Pittsburgh Sleep Quality Index. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Sleep quality is measured by the PSQI. The global score (0–21) is the sum of seven components; higher scores indicate worse sleep quality. A score =5 indicates clinical sleep disturbance.;Hospital anxiety and depression scale. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Hospital Anxiety and Depression Scale consists of depression and anxiety subscales (7 items each, score 0–21 per subscale). A score =8 on either subscale indicates significant clinical symptoms. Each item is scored 0–3 and summed.;Chrononutrition Profile – Questionnaire (CP-Q) for measuring eating time disturbance. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Chrono nutrition is assessed using the CP-Q. The global score (0–12) sums six components: breakfast skipping, evening eating, night eating, and eating window. Higher scores indicate greater circadian misalignment of eating patterns.	—

Measure

Time frame

To determine the participants' chronotype, the standard version of the Munich ChronoType Questionnaire (MCTQ) will be used. The primary outcome measure is the sleep-corrected midpoint of sleep on work-free days (MSFsc), which serves as the proxy for chronotype and is calculated as MSFsc = MSF – (SDf – SDweek) / 2. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Chronotype is assessed using the MCTQ. The primary measure is MSFsc (midpoint of sleep on work-free days corrected for sleep debt), calculated in hours. Lower MSFsc indicates morningness, higher values indicate eveningness.;Pittsburgh Sleep Quality Index. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Sleep quality is measured by the PSQI. The global score (0–21) is the sum of seven components; higher scores indicate worse sleep quality. A score =5 indicates clinical sleep disturbance.;Hospital anxiety and depression scale. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Hospital Anxiety and Depression Scale consists of depression and anxiety subscales (7 items each, score 0–21 per subscale). A score =8 on either subscale indicates significant clinical symptoms. Each item is scored 0–3 and summed.;Chrononutrition Profile – Questionnaire (CP-Q) for measuring eating time disturbance. Timepoint: Before the start of the intervention, and 6 and 12 months after the intervention. Method of measurement: Chrono nutrition is assessed using the CP-Q. The global score (0–12) sums six components: breakfast skipping, evening eating, night eating, and eating window. Higher scores indicate greater circadian misalignment of eating patterns.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Salarifar

Tehran University of Medical Sciences

mojtabasalarifar@gmail.com+98 21 8802 9600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026