Effects of Connective Tissue Massage in Patients With Chronic Insomnia
ConditionChronic Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSaglik Bilimleri Universitesi
About this trial
This randomized controlled trial will investigate the effects of connective tissue massage on insomnia severity, objective and subjective sleep outcomes, and stress- and autonomic-related biomarkers in adults with chronic insomnia. Chronic insomnia is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep and is associated with impaired daytime functioning, reduced cognitive performance, and diminished quality of life. Non-pharmacological interventions may provide a safe alternative or complementary approach for individuals with chronic insomnia.
A total of 74 adults diagnosed with chronic insomnia by a neurologist and who have not used sleep medication during the previous four weeks will be enrolled. Participants will be randomly allocated to either a connective tissue massage group or a control group. The intervention group will receive 12 sessions of connective tissue massage over a four-week period, with three sessions per week, in addition to sleep hygiene education. The control group will receive sleep hygiene education alone.
Assessments will be performed at baseline and immediately after the four-week intervention period. The primary outcome will be the change in insomnia severity, assessed using the Insomnia Severity Index. Secondary outcomes will include objective sleep parameters recorded by actigraphy over five consecutive days, including total sleep time, sleep efficiency, sleep onset latency, and wake after sleep onset. Blood biomarkers associated with hypothalamic-pituitary-adrenal axis activity and autonomic regulation, including cortisol, DHEA-S, alpha-amylase, and oxytocin, will also be assessed. Subjective sleep quality and sleep hygiene will be evaluated using the Pittsburgh Sleep Quality Index and Sleep Hygiene Index, respectively. Adherence to sleep hygiene recommendations will additionally be assessed using sleep diaries.
The study aims to determine whether connective tissue massage combined with sleep hygiene education is more effective than sleep hygiene education alone in reducing insomnia severity and improving objective and subjective sleep outcomes and selected physiological biomarkers in adults with chronic insomnia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years, of either sex.
Diagnosis of chronic insomnia disorder according to the International -Classification of Sleep Disorders, Third Edition, Turkish version (ICSD-3-TR), established by a neurologist.
Difficulty initiating or maintaining sleep occurring at least three nights per week for at least three months, consistent with ICSD-3-TR diagnostic criteria.
No use of pharmacological agents for insomnia during the previous four weeks, including benzodiazepines, non-benzodiazepine hypnotics, melatonin and melatonin receptor agonists, sedating antidepressants, and anxiolytics.
Disqualifiers
History of shift work during the previous month or lifestyle changes that may disrupt circadian rhythm.
Presence of obstructive sleep apnea syndrome, circadian rhythm sleep-wake disorders, or other primary sleep disorders.
History of any neurological diagnosis, such as epilepsy or Parkinson's disease, or psychiatric diagnosis, such as depression or bipolar disorder.
Presence of an open wound, infection, dermatitis, or other dermatological condition impairing skin integrity in the area where connective tissue massage will be applied.
Trial design
Design model
Parallel
Treatments tested in this trial
Connective Tissue Massage
Procedure/SurgeryConnective tissue massage will be administered by a physiotherapist three times per week for four consecutive weeks, for a total of 12 sessions.
Sleep Hygiene Education
BehavioralStandardized sleep hygiene education based on clinical guidelines will be provided verbally by a neurologist following the baseline assessment, and the same content will be provided to participants in written brochure format.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Connective Tissue Massage + Sleep Hygiene EducationExperimental treatment 2 interventions
Group B: Sleep Hygiene EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index Score
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI). Assessments will be performed at baseline and immediately after the four-week intervention period.
Time frame
From baseline to 4 weeksSecondary outcomes
1
Change in Cortisol Level
Cortisol level will be assessed as a blood biomarker reflecting hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame
From baseline to immediately after the 4-week intervention period2
Change in DHEA-S Level
DHEA-S level will be assessed as a blood biomarker related to hypothalamic-pituitary-adrenal axis activity. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame
From baseline to immediately after the 4-week intervention period3
Change in Alpha-Amylase Level
Alpha-amylase level will be assessed as a blood biomarker related to autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame
From baseline to immediately after the 4-week intervention period4
Change in Oxytocin Level
Oxytocin level will be assessed as a blood biomarker related to neuroendocrine and autonomic regulation. The change from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame
From baseline to immediately after the 4-week intervention periodSponsors and contacts
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Source ClinicalTrials.gov
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