Sleep Disorder (Disorder)NCT07638605
Sensory and Behavioral Sleep Training
A study testing Sleep Hygiene Education, Sensory-Based Sleep Intervention and Behavioral Relaxation Intervention in people with Sleep Disorder (Disorder), run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- Sleep Hygiene Education, Sensory-Based Sleep Intervention and Behavioral Relaxation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Willing to participate voluntarily and provide informed consent
Who cannot join
- 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
- Mini-Mental State Examination score below 24
- Regular meditation or similar mind-body practice for more than 15 minutes per day
- Body mass index greater than 34.9 kg/m²
- Previous participation in a sleep hygiene education program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Sensory and Behavioral Sleep Training in Individuals With Sleep Problems
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.
Read the detailed description
This study is a three-arm, randomized controlled, single-blind trial designed to compare sensory-based and behavioral sleep interventions in individuals with poor sleep quality.
Eligible participants are randomly assigned to one of three parallel groups: a control group receiving standardized sleep hygiene education, a sensory-based intervention group, or a behavioral intervention group. Randomization is performed using a computer-generated random-number sequence. Attention is given to maintaining a balanced distribution of age and sex across the study groups. Because the researcher responsible for delivering the interventions is aware of group allocation, participant and intervention-provider blinding is not feasible. However, study data are coded and analyzed by an independent statistician who is blinded to group allocation.
All participants receive a standardized sleep hygiene education program lasting six weeks. The education addresses behavioral and environmental factors associated with sleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing exposure to stimulating activities, and arranging the sleep environment in terms of light, noise, and room temperature. Educational content is delivered through an online social media platform and supported by weekly telephone follow-up.
Participants allocated to the sensory-based intervention group receive the sleep hygiene education program together with sensory regulation strategies. These strategies include the inhalation of lavender and orange essential oils before sleep and exposure to pink noise during the transition to sleep. Participants are instructed in the standardized home-based use of these strategies, and adherence is monitored through weekly telephone calls.
Participants allocated to the behavioral intervention group receive the sleep hygiene education program together with progressive muscle relaxation and diaphragmatic breathing exercises. Audio recordings and written instructions are provided to support the standardized home-based practice of these techniques. Adherence is also monitored through weekly telephone calls.
The control group receives the standardized sleep hygiene education program without the additional sensory-based or behavioral components.
Assessments are conducted before the intervention and after completion of the six-week intervention period under standardized conditions. The primary focus of the study is the comparison of changes in sleep quality among the three groups. Additional assessments examine sleep hygiene, anxiety symptoms, quality of life, activity-role balance, sensory processing patterns, autonomic nervous system activity, and wearable-device-based sleep parameters.
Autonomic nervous system activity is assessed using heart rate variability recordings. Objective sleep parameters are monitored using a wearable activity-tracking device throughout the intervention period. Participants also maintain a daily sleep diary to record sleep-related routines and behaviors.
Intervention materials, application instructions, follow-up procedures, and assessment conditions are standardized across participants to support intervention fidelity and comparability. Participants are asked not to begin a new sleep-related treatment during the study period.
Study data are recorded using standardized data collection forms and participant identification codes. Data entries are reviewed for completeness, consistency, and values outside predefined ranges before statistical analysis. Where discrepancies are identified, entries are checked against the original assessment forms, sleep diaries, and device records. Access to identifiable information is restricted to authorized study personnel, and the analysis dataset is prepared in coded form. Missing data and protocol deviations are documented and addressed in accordance with the prespecified statistical analysis procedures.
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- Sleep Hygiene Education, Sensory-Based Sleep Intervention, Behavioral Relaxation Intervention
- Keywords
- sleep disorder, sensory-based, behavioral
- Medical subject headings
- Sleep Wake Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
Participants 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 InterventionBehavioural
Participants 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 InterventionBehavioural
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Active comparator | Participants in this group receive a standardized six-week sleep hygiene education program. The program includes recommendations on maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing stimulating activities and screen exposure, and arranging the sleep environment in terms of light, noise, and room temperature. Participants receive weekly follow-up telephone calls to support adherence to the program. Receives: Behavioral: Sleep Hygiene Education |
| Sleep Hygiene Education Plus Sensory-Based Intervention | Experimental | Participants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls. Receives: Behavioral: Sleep Hygiene Education; Behavioral: Sensory-Based Sleep Intervention |
| Sleep Hygiene Education Plus Behavioral Intervention | Experimental | Participants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls. Receives: Behavioral: Sleep Hygiene Education; Behavioral: Behavioral Relaxation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 6-week intervention
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.
Measured: Baseline and immediately after completion of the 6-week intervention
Secondary outcomes (5)
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.
Measured: Baseline and immediately after completion of the 6-week intervention
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.
Measured: Baseline and immediately after completion of the 6-week intervention
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.
Measured: Baseline and immediately after completion of the 6-week intervention
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.
Measured: Baseline and immediately after completion of the 6-week intervention
Change in Resting Heart Rate Variability Parameters
Resting heart rate variability is recorded using a Polar H10 chest-strap sensor following a 5-minute seated rest period. Parameters include mean RR interval, heart rate, SDNN, RMSSD, pNN50, LF power, HF power, LF/HF ratio, normalized LF and HF power, and autonomic nervous system indices. Changes in each parameter are evaluated.
Measured: Baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Dec 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in parallel to one of three study groups: sleep hygiene education alone, sleep hygiene education combined with a sensory-based intervention, or sleep hygiene education combined with a behavioral intervention. Each participant remains in the assigned group throughout the six-week intervention period, and outcomes are assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yazicioglu, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638605
- Sponsor's protocol ID
- Yazicioglu_1
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the informed consent obtained from participants does not include permission for public or unrestricted sharing of individual-level data. In addition, the relatively small sample size and the detailed demographic, clinical, and physiological data collected may increase the risk of participant re-identification. De-identified aggregate study results will be reported in the thesis, scientific publications, and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Sensory and Behavioral Sleep Training in Individuals With Sleep Problems
- ClinicalTrials.gov ID
- NCT07638605
- Acronym / sponsor ID
- Yazicioglu_1
- Conditions
- Sleep Disorder (Disorder)
- Keywords
- sleep disorder, sensory-based, behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a three-arm, randomized controlled, single-blind trial designed to compare sensory-based and behavioral sleep interventions in individuals with poor sleep quality.
Eligible participants are randomly assigned to one of three parallel groups: a control group receiving standardized sleep hygiene education, a sensory-based intervention group, or a behavioral intervention group. Randomization is performed using a computer-generated random-number sequence. Attention is given to maintaining a balanced distribution of age and sex across the study groups. Because the researcher responsible for delivering the interventions is aware of group allocation, participant and intervention-provider blinding is not feasible. However, study data are coded and analyzed by an independent statistician who is blinded to group allocation.
All participants receive a standardized sleep hygiene education program lasting six weeks. The education addresses behavioral and environmental factors associated with sleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing exposure to stimulating activities, and arranging the sleep environment in terms of light, noise, and room temperature. Educational content is delivered through an online social media platform and supported by weekly telephone follow-up.
Participants allocated to the sensory-based intervention group receive the sleep hygiene education program together with sensory regulation strategies. These strategies include the inhalation of lavender and orange essential oils before sleep and exposure to pink noise during the transition to sleep. Participants are instructed in the standardized home-based use of these strategies, and adherence is monitored through weekly telephone calls.
Participants allocated to the behavioral intervention group receive the sleep hygiene education program together with progressive muscle relaxation and diaphragmatic breathing exercises. Audio recordings and written instructions are provided to support the standardized home-based practice of these techniques. Adherence is also monitored through weekly telephone calls.
The control group receives the standardized sleep hygiene education program without the additional sensory-based or behavioral components.
Assessments are conducted before the intervention and after completion of the six-week intervention period under standardized conditions. The primary focus of the study is the comparison of changes in sleep quality among the three groups. Additional assessments examine sleep hygiene, anxiety symptoms, quality of life, activity-role balance, sensory processing patterns, autonomic nervous system activity, and wearable-device-based sleep parameters.
Autonomic nervous system activity is assessed using heart rate variability recordings. Objective sleep parameters are monitored using a wearable activity-tracking device throughout the intervention period. Participants also maintain a daily sleep diary to record sleep-related routines and behaviors.
Intervention materials, application instructions, follow-up procedures, and assessment conditions are standardized across participants to support intervention fidelity and comparability. Participants are asked not to begin a new sleep-related treatment during the study period.
Study data are recorded using standardized data collection forms and participant identification codes. Data entries are reviewed for completeness, consistency, and values outside predefined ranges before statistical analysis. Where discrepancies are identified, entries are checked against the original assessment forms, sleep diaries, and device records. Access to identifiable information is restricted to authorized study personnel, and the analysis dataset is prepared in coded form. Missing data and protocol deviations are documented and addressed in accordance with the prespecified statistical analysis procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned in parallel to one of three study groups: sleep hygiene education alone, sleep hygiene education combined with a sensory-based intervention, or sleep hygiene education combined with a behavioral intervention. Each participant remains in the assigned group throughout the six-week intervention period, and outcomes are assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Active comparator | Behavioral: Sleep Hygiene EducationParticipants in this group receive a standardized six-week sleep hygiene education program. The program includes recommendations on maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing stimulating activities and screen exposure, and arranging the sleep environment in terms of light, noise, and room temperature. Participants receive weekly follow-up telephone calls to support adherence to the program. |
| Sleep Hygiene Education Plus Sensory-Based Intervention | Experimental | Behavioral: Sleep Hygiene Education, Behavioral: Sensory-Based Sleep InterventionParticipants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls. |
| Sleep Hygiene Education Plus Behavioral Intervention | Experimental | Behavioral: Sleep Hygiene Education, Behavioral: Behavioral Relaxation InterventionParticipants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Willing to participate voluntarily and provide informed consent
Key exclusion criteria (8 listed)
- 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
- Mini-Mental State Examination score below 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene EducationParticipants 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. | Behavioural | Sleep Hygiene Education, Sleep Hygiene Education Plus Behavioral Intervention, Sleep Hygiene Education Plus Sensory-Based Intervention |
| Sensory-Based Sleep InterventionParticipants 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. | Behavioural | Sleep Hygiene Education Plus Sensory-Based Intervention |
| Behavioral Relaxation InterventionParticipants 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. | Behavioural | Sleep Hygiene Education Plus Behavioral Intervention |
Primary outcome
Change in Pittsburgh Sleep Quality Index Global Score
Time frame: Baseline and immediately after completion of the 6-week intervention
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.
Change in Sleep Hygiene Index Total Score
Time frame: Baseline and immediately after completion of the 6-week intervention
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.
5 secondary outcomes
Change in Beck Anxiety Inventory Total Score
Time frame: Baseline and immediately after completion of the 6-week intervention
Change in WHOQOL-BREF Domain Scores
Time frame: Baseline and immediately after completion of the 6-week intervention
Change in Occupational Balance Questionnaire-11 Total Score
Time frame: Baseline and immediately after completion of the 6-week intervention
Change in Adolescent/Adult Sensory Profile Quadrant Scores
Time frame: Baseline and immediately after completion of the 6-week intervention
Change in Resting Heart Rate Variability Parameters
Time frame: Baseline and immediately after completion of the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the informed consent obtained from participants does not include permission for public or unrestricted sharing of individual-level data. In addition, the relatively small sample size and the detailed demographic, clinical, and physiological data collected may increase the risk of participant re-identification. De-identified aggregate study results will be reported in the thesis, scientific publications, and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education, Sensory-Based Sleep Intervention and Behavioral Relaxation Intervention in people with Sleep Disorder (Disorder), run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pittsburgh Sleep Quality Index Global Score (time frame: Baseline and immediately after completion of the 6-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.