A Study on the Application of Aromatherapy Combined With Transcranial Magnetic Stimulation in Insomnia of Stroke Patients

NCT07202806 | Not Yet Recruiting

• 1 other identifier: 2024B1366
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exploring the application efficacy of aromatherapy combined with transcranial magnetic stimulation on insomnia in patients with cerebral stroke

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Respiratory sleep monitoring

  The average length of sleep in a week Sleep breathing monitoring was determined by evaluation before and after treatment. The main purpose of this study was to observe whether the average sleep time of patients increased significantly after treatment.

  From enrollment to the end of treatment for 3 weeks

Secondary Outcomes (1)

• Pittsburgh sleep quality index,PSQI

  From enrollment to the end of treatment for 3 weeks

Study Arms (2)

transcranial magnetic stimulation

NO INTERVENTION

Aromatherapy + transcranial magnetic stimulation

EXPERIMENTAL

Experimental:Aromatherapy + transcranial magnetic stimulation 1.Aromatherapy is made from self-made sachet of traditional Chinese medicine.Its components (albizzia, Angelica dahurica, cardamom, Polygala, Evodia, Magnolia, Acorus calamus) are 10g each. Place the pillow 1 hour in advance. It is forbidden to play with your mobile phone or turn off the lights before going to bed.2.The r repetitive transcranial magnetic acupuncture apparatus produced by Jiangxi brain Control Technology Development Co., Ltd. is used and operated by professional therapists.Before treatment, the resting exercise threshold of each patient was tested: 10 pulse stimuli were given to find out the lowest stimulus intensity that could cause more than 50 microvolts.Parameter setting: 90% RMT 1Hz, each sequence lasts 12s, stimulation 10s, interval 2s. The treatment time was 20min/, once per day for 5 days per week, lasting for 3 weeks.

Behavioral: Aromatherapy

Interventions

Aromatherapy BEHAVIORAL

1.Aromatherapy is made from self-made sachet of traditional Chinese medicine.Its components (albizzia, Angelica dahurica, cardamom, Polygala, Evodia, Magnolia, Acorus calamus) are 10g each. Place the pillow 1 hour in advance. It is forbidden to play with your mobile phone or turn off the lights before going to bed.

Aromatherapy + transcranial magnetic stimulation

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of stroke
• Insomnia patients
• Sign the informed consent form, cooperate voluntarily
• Accord with the diagnosis of "insomnia" in traditional Chinese medicine
• Evaluation has no taboo on transcranial magnetism
• The age range is between 24 and 65

You may not qualify if:

• Disturbance of consciousness
• Cognitive impairment
• Mental abnormality
• Sleep apnea syndrome
• Restless leg syndrome

Sponsors & Collaborators

• Dandan Wu: lead

MeSH Terms

Conditions

Stroke

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 2, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10