Sensory and Behavioral Sleep Training
ConditionSleep Disorder (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorAtlas University
About this trial
Sleep problems may affect individuals' daily functioning, emotional well-being, cognitive performance, and quality of life. Non-pharmacological approaches, including sleep hygiene education, sensory-based strategies, and behavioral relaxation techniques, may help individuals develop healthier sleep routines. However, studies directly comparing sensory-based and behavioral approaches are limited.
The aim of this randomized controlled study is to compare the effects of sensory-based and behavioral sleep interventions in adults experiencing poor sleep quality. Participants are randomly assigned to one of three groups: a sleep hygiene education group, a sensory-based intervention group, or a behavioral intervention group. All participants receive a standardized six-week sleep hygiene education program. In addition, the sensory-based intervention group uses aromatherapy and pink noise, while the behavioral intervention group practices progressive muscle relaxation and diaphragmatic breathing exercises.
Participants are assessed before and after the six-week intervention period. The study examines changes in sleep quality and sleep-related behaviors, as well as anxiety, quality of life, activity-role balance, sensory processing characteristics, autonomic nervous system activity, and sleep parameters. The study is expected to provide information about the potential contribution of sensory-based and behavioral strategies to the management of sleep problems.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 20 to 55 years
Pittsburgh Sleep Quality Index global score of 5 or higher
Able to use a smartphone
Able to understand and speak Turkish
Disqualifiers
History of substance dependence
Presence of a chronic physical illness or a diagnosed psychiatric disorder
Regular medication use, particularly sleep-regulating medications, antidepressants, or similar medications that may affect sleep
Diagnosis of a sleep disorder, such as insomnia or sleep apnea
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep Hygiene Education
BehavioralParticipants receive a standardized six-week sleep hygiene education program. The program covers sleep physiology and the use of a sleep diary, the principles and importance of sleep hygiene, behavioral and cognitive strategies that may support sleep, characteristics of an appropriate sleep environment, evaluation of current sleep habits, factors affecting sleep quality, and reinforcement of acquired sleep-related behaviors. The educational content is delivered remotely, and adherence is supported through weekly telephone follow-up.
Sensory-Based Sleep Intervention
BehavioralParticipants receive a home-based sensory intervention in addition to sleep hygiene education. The intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants are instructed to apply a few drops of the essential oils to cotton or gauze placed at an appropriate distance for inhalation, or to disperse the oils into the room using a diffuser. The sensory strategies are introduced by the researcher and are applied regularly in the home environment throughout the six-week intervention period. Adherence is monitored through weekly telephone follow-up.
Behavioral Relaxation Intervention
BehavioralParticipants receive a home-based behavioral relaxation intervention in addition to sleep hygiene education. The intervention consists of progressive muscle relaxation exercises and diaphragmatic breathing exercises performed before bedtime. Participants are provided with an audio recording and written instructions to support standardized practice. Progressive muscle relaxation involves the systematic relaxation of different muscle groups, while diaphragmatic breathing is used to support physiological relaxation. The exercises are practiced regularly throughout the six-week intervention period, and adherence is monitored through weekly telephone follow-up.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Sleep Hygiene EducationActive comparator 1 intervention
Group B: Sleep Hygiene Education Plus Sensory-Based InterventionExperimental treatment 2 interventions
Group C: Sleep Hygiene Education Plus Behavioral InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Pittsburgh Sleep Quality Index Global Score
Sleep quality is assessed using the Pittsburgh Sleep Quality Index. The scale evaluates subjective sleep quality during the previous month and provides a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The outcome is the change in the global score from baseline to the post-intervention assessment.
Time frame
Baseline and immediately after completion of the 6-week intervention2
Change in Sleep Hygiene Index Total Score
Sleep hygiene is assessed using the Sleep Hygiene Index, which evaluates the frequency of behaviors and environmental practices that may negatively affect sleep. Higher total scores indicate poorer sleep hygiene. The outcome is the change in the total score from baseline to the post-intervention assessment.
Time frame
Baseline and immediately after completion of the 6-week interventionSecondary outcomes
1
Change in Beck Anxiety Inventory Total Score
Anxiety symptoms are assessed using the 21-item Beck Anxiety Inventory. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater anxiety symptom severity. The outcome is the change in the total score from baseline to the post-intervention assessment.
Time frame
Baseline and immediately after completion of the 6-week intervention2
Change in WHOQOL-BREF Domain Scores
Quality of life is assessed using the World Health Organization Quality of Life-BREF. The instrument evaluates physical health, psychological health, social relationships, and environmental quality of life. Domain scores are calculated separately, with higher scores indicating better quality of life. Changes in each domain score are evaluated.
Time frame
Baseline and immediately after completion of the 6-week intervention3
Change in Occupational Balance Questionnaire-11 Total Score
Occupational balance is assessed using the 11-item Occupational Balance Questionnaire. The total score ranges from 0 to 33. Higher scores indicate better perceived balance in the amount and variation of daily activities. The outcome is the change in the total score from baseline to the post-intervention assessment.
Time frame
Baseline and immediately after completion of the 6-week intervention4
Change in Adolescent/Adult Sensory Profile Quadrant Scores
Sensory processing patterns are assessed using the Adolescent/Adult Sensory Profile. The instrument evaluates four patterns: low registration, sensation seeking, sensory sensitivity, and sensation avoiding. Scores are calculated separately for each quadrant. Higher scores indicate more frequent behaviors associated with the relevant sensory processing pattern.
Time frame
Baseline and immediately after completion of the 6-week interventionSponsors and contacts
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Source ClinicalTrials.gov