Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 65 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 74 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Inclusion Criteria:
- 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.
- Insomnia Severity Index score of ≥15, indicating moderate to severe insomnia. Ability to read and write.
- Standardized Mini-Mental State Examination score of ≥24, indicating adequate cognitive status.
- Willingness to participate in the study and provision of written informed consent.
- Exclusion Criteria:
- 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.
- Regular use of medications that may affect sleep, including antidepressants, beta-blockers, or corticosteroids.
- Initiation of any pharmacological treatment for insomnia, including sleep medications or sedatives, during the four-week study period.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Connective Tissue Massage + Sleep Hygiene Education
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
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 PROCEDURE
Connective 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 BEHAVIORAL
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in Insomnia Severity Index Score
Plazo: From baseline to 4 weeks
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.
Medidas secundarias
Change in Cortisol Level
Plazo: From baseline to immediately after the 4-week intervention period
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.
Change in DHEA-S Level
Plazo: From baseline to immediately after the 4-week intervention period
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.
Change in Alpha-Amylase Level
Plazo: From baseline to immediately after the 4-week intervention period
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.
Change in Oxytocin Level
Plazo: From baseline to immediately after the 4-week intervention period
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.
Change in Total Sleep Time
Plazo: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
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.
Change in Sleep Efficiency
Plazo: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
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.
Change in Sleep Onset Latency
Plazo: 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.
From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
Change in Wake After Sleep Onset (WASO)
Plazo: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
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.
Change in Number of Nighttime Awakenings
Plazo: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
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.
Change in Sleep Fragmentation Index
Plazo: From baseline to immediately after the 4-week intervention period; actigraphy will be recorded for 5 consecutive days at each assessment point.
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.
Change in Pittsburgh Sleep Quality Index Score
Plazo: From baseline to immediately after the 4-week intervention period
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.
Change in Sleep Hygiene Index Score
Plazo: From baseline to immediately after the 4-week intervention period
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Sultan 2.Abdulhamid Khan Educational and Research HospitalIstanbul, Turkey (Türkiye)Estado desconocido
Equipo y fechas
- Patrocinador principal
- Saglik Bilimleri Universitesi
- Inicio del estudio
- 2026-12 Estimado
- Finalización primaria
- 2027-07 Estimado
- Finalización del estudio
- 2027-07 Estimado
- Primera publicación
- 18 ago 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
The Effects of Connective Tissue Massage in Patients With Chronic Insomnia: A Randomized Controlled Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026