An interventional study of Connective Tissue Massage and Sleep Hygiene Education in Chronic Insomnia, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 74 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure, in addition to 12 sessions of connective tissue massage delivered by a physiotherapist over four weeks, three sessions per week.
Procedure: Connective Tissue Massage · Behavioral: Sleep Hygiene Education
Participants will receive standardized sleep hygiene education provided verbally by a neurologist and as a written brochure. No connective tissue massage will be provided during the four-week study period.
Behavioral: Sleep Hygiene Education
Connective tissue massage will be administered by a physiotherapist three times per week for four consecutive weeks, for a total of 12 sessions.
Standardized 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.
Change in Insomnia Severity Index Score
Change in insomnia severity will be assessed using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity, whereas lower scores indicate fewer insomnia symptoms. Scores are interpreted as follows: 0-7, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, moderate clinical insomnia; and 22-28, severe clinical insomnia. The change in total score from baseline to the end of the intervention will be evaluated.
Time frame: From baseline to 4 weeks
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 period
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 period
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 period
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 period
Change in Total Sleep Time
Total sleep time will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in total sleep time will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Efficiency
Sleep efficiency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep efficiency will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Onset Latency
From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Time frame: Sleep onset latency will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep onset latency will be evaluated.
Change in Wake After Sleep Onset (WASO)
Wake after sleep onset (WASO) will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in WASO will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Number of Nighttime Awakenings
The number of nighttime awakenings will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in the number of awakenings will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Sleep Fragmentation Index
Sleep fragmentation index will be assessed objectively using actigraphy over 5 consecutive days at baseline and after the 4-week intervention period. The change in sleep fragmentation index will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Pittsburgh Sleep Quality Index Score
Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The change in PSQI score from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period
Change in Sleep Hygiene Index Score
Sleep hygiene behaviors will be assessed using the Sleep Hygiene Index (SHI). The change in SHI score from baseline to immediately after the 4-week intervention period will be evaluated.
Time frame: From baseline to immediately after the 4-week intervention period
Plan to share: Undecided — A decision regarding the sharing of individual participant data with other researchers has not yet been made. Any future data-sharing decisions will take into consideration participant confidentiality, applicable ethical requirements, and institutional policies.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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