Authors
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Atlas University -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
This study is a three‐arm, randomized controlled, single‐blind trial designed to comparesensory‐based and behavioral sleep interventions in individuals with poor sleep quality.Eligible participants are randomly assigned to one of three parallel groups: a controlgroup receiving standardized sleep hygiene education, a sensory‐based intervention group,or a behavioral intervention group. Randomization is performed using a computer‐generatedrandom‐number sequence. Attention is given to maintaining a balanced distribution of ageand sex across the study groups. Because the researcher responsible for delivering theinterventions is aware of group allocation, participant and intervention‐providerblinding is not feasible. However, study data are coded and analyzed by an independentstatistician who is blinded to group allocation.All participants receive a standardized sleep hygiene education program lasting sixweeks. The education addresses behavioral and environmental factors associated withsleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine,and alcohol before bedtime, reducing exposure to stimulating activities, and arrangingthe sleep environment in terms of light, noise, and room temperature. Educational contentis delivered through an online social media platform and supported by weekly telephonefollow‐up.Participants allocated to the sensory‐based intervention group receive the sleep hygieneeducation program together with sensory regulation strategies. These strategies includethe inhalation of lavender and orange essential oils before sleep and exposure to pinknoise during the transition to sleep. Participants are instructed in the standardizedhome‐based use of these strategies, and adherence is monitored through weekly telephonecalls.Participants allocated to the behavioral intervention group receive the sleep hygieneeducation program together with progressive muscle relaxation and diaphragmatic breathingexercises. Audio recordings and written instructions are provided to support thestandardized home‐based practice of these techniques. Adherence is also monitored throughweekly telephone calls.The control group receives the standardized sleep hygiene education program without theadditional sensory‐based or behavioral components.Assessments are conducted before the intervention and after completion of the six‐weekintervention period under standardized conditions. The primary focus of the study is thecomparison of changes in sleep quality among the three groups. Additional assessmentsexamine sleep hygiene, anxiety symptoms, quality of life, activity‐role balance, sensoryprocessing patterns, autonomic nervous system activity, and wearable‐device‐based sleepparameters.Autonomic nervous system activity is assessed using heart rate variability recordings.Objective sleep parameters are monitored using a wearable activity‐tracking devicethroughout the intervention period. Participants also maintain a daily sleep diary torecord sleep‐related routines and behaviors.Intervention materials, application instructions, follow‐up procedures, and assessmentconditions are standardized across participants to support intervention fidelity andcomparability. Participants are asked not to begin a new sleep‐related treatment duringthe study period.Study data are recorded using standardized data collection forms and participantidentification codes. Data entries are reviewed for completeness, consistency, and valuesoutside predefined ranges before statistical analysis. Where discrepancies areidentified, entries are checked against the original assessment forms, sleep diaries, anddevice records. Access to identifiable information is restricted to authorized studypersonnel, and the analysis dataset is prepared in coded form. Missing data and protocoldeviations are documented and addressed in accordance with the prespecified statisticalanalysis procedures.
Epistemonikos ID: 9ea21ffbaa8e1aef3017a7cfa1e5bc614f56a72a
First added on: Jun 11, 2026