Sleep QualityNCT07261124
Effect of Health Promotion Model-Based Oculomotor Exercise Program on Sleep Quality in Older Adults
A study testing Oculomotor Exercise Program in people with Sleep Quality and Older Adults (65 Years and Older), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Older Adults (65 Years and Older)
- What is being tested?
- Oculomotor Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or older
- Residing in the nursing home for at least 6 months
- Scoring 4 or above on the Mini-Cog test
- Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 (indicating poor sleep quality)
- No diagnosis of psychiatric disorders such as depression, bipolar disorder, or schizophrenia
- No diagnosis of serious sleep disorders such as sleep apnea or narcolepsy
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- No medical condition causing frequent nocturnal awakenings, such as nocturia
- Not using antipsychotic or other medications that may affect sleep quality
- Having chronic diseases (e.g., diabetes mellitus, hypertension, coronary artery disease) that are controlled with pharmacological treatment
- No communication problems
Who cannot join
- Older adults unable to perform self-care independently
- Older adults with dizziness or balance problems
- Participants who are hospitalized for any reason during the follow-up or exercise sessions will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
A Nursing home facility in Istanbul
Istanbul, Istanbul
Hande Sabandüzen, PhD Candidate, +905455693484, handesabanduzen@ogr.iuc.edu.tr
About this study
Official title: Investigation of the Effect of Health Promotion Model Based Oculomotor Exercise Program on Sleep Quality in Elderly Living in a Nursing Home: A Randomized Controlled Trial
The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home.
The main questions it aims to answer are:
Does the Health Promotion Model-based oculomotor exercise program improve sleep quality in older adults living in a nursing home? Does participation in the program enhance self-efficacy and promote better health behaviors related to sleep?
Read the detailed description
This randomized controlled trial aims to evaluate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. Participants in the experimental group will receive an approximately 3-month structured intervention integrating oculomotor exercises and motivational interviewing techniques, while the control group will receive no intervention and continue with their usual daily routines.
The intervention is designed according to the components of the Health Promotion Model, targeting self-efficacy and behavior change processes. During the first meeting, participants complete baseline assessments, including the Personal Information Form, Sleep Beliefs Scale, Stages of Change Inventory, DSM-5 Sleep Disorder Scale, and Pittsburgh Sleep Quality Index (PSQI). Over four weeks, participants in the experimental group perform oculomotor exercises three times a week (Monday, Wednesday, Friday) and attend weekly motivational interviewing sessions focusing on awareness, perceived benefits, self-efficacy, decision balance, empowerment, and commitment to behavior. Weekly DSM-5 Sleep Disorder assessments are also conducted.
Follow-up sessions continue during the second and third months to support maintenance of behavior change, with monthly evaluations using the PSQI and Stages of Change Inventory. Sleep diaries are used throughout to monitor participants' sleep patterns. The primary outcome is sleep quality, and secondary outcomes include self-efficacy and behavioral stage of change.
- Conditions
- Sleep Quality, Older Adults (65 Years and Older)
- Being tested
- Oculomotor Exercise Program
- Keywords
- sleep quality, health promotion, Eye Movements, nursing, aged
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculomotor Exercise ProgramBehavioural
This intervention is a structured oculomotor exercise program based on the Health Promotion Model, developed to improve sleep quality among older adults living in a nursing home. The program focuses on enhancing visual-motor coordination and relaxation through systematic eye movement exercises.
Participants in the experimental group perform oculomotor exercises three times per week for four consecutive weeks under researcher supervision. The program includes educational support and brief motivational guidance to encourage adherence and consistency. Follow-up sessions are conducted during the following two months to monitor sleep patterns and maintain behavioral improvement.
This intervention differs from traditional exercise programs by targeting the oculomotor system and incorporating health promotion principles to support better sleep and overall well-being in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants in this group will receive a structured oculomotor exercise program designed according to the Health Promotion Model. The program includes oculomotor exercises performed three times a week and weekly motivational interviewing sessions to enhance self-efficacy and adherence. Sleep quality and behavioral change outcomes will be assessed at baseline and post-intervention. Receives: Behavioral: Oculomotor Exercise Program |
| Control Group | No intervention | Participants in this group will not receive any intervention. They will continue their usual daily activities and will be evaluated using the same measurement tools and time points as the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, duration, and disturbances over the previous month. Higher scores indicate poorer sleep quality.
Measured: Baseline, 4 weeks, 2 and 3 months after the intervention
Secondary outcomes (1)
Stage of Behavioral Change
Behavioral change related to sleep habits will be assessed using the Stages of Change Inventory. The scale evaluates participants' progression through different stages of adopting and maintaining healthy sleep behaviors.
Measured: Baseline, 4 weeks, 2 and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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 will be randomly assigned to either the experimental or control group using a parallel design. The experimental group will receive a Health Promotion Model-based oculomotor exercise program while the control group will receive no tervention and continue their usual daily activities. Both groups will be evaluated simultaneously at baseline and after the intervention using standardized scales for sleep quality and behavioral change.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Sabandüzen, Istanbul University - Cerrahpasa
- Investigators
- Hande sabandüzen, PhD Candidate, Principal investigator, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261124
- Sponsor's protocol ID
- IUC_LEE_HS_1
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Health Promotion Model Based Oculomotor Exercise Program on Sleep Quality in Elderly Living in a Nursing Home: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07261124
- Acronym / sponsor ID
- IUC_LEE_HS_1
- Conditions
- Sleep Quality, Older Adults (65 Years and Older)
- Keywords
- sleep quality, health promotion, Eye Movements, nursing, aged
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Dec 2025 (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.
The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home.
The main questions it aims to answer are:
Does the Health Promotion Model-based oculomotor exercise program improve sleep quality in older adults living in a nursing home? Does participation in the program enhance self-efficacy and promote better health behaviors related to sleep?
Detailed description
This randomized controlled trial aims to evaluate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. Participants in the experimental group will receive an approximately 3-month structured intervention integrating oculomotor exercises and motivational interviewing techniques, while the control group will receive no intervention and continue with their usual daily routines.
The intervention is designed according to the components of the Health Promotion Model, targeting self-efficacy and behavior change processes. During the first meeting, participants complete baseline assessments, including the Personal Information Form, Sleep Beliefs Scale, Stages of Change Inventory, DSM-5 Sleep Disorder Scale, and Pittsburgh Sleep Quality Index (PSQI). Over four weeks, participants in the experimental group perform oculomotor exercises three times a week (Monday, Wednesday, Friday) and attend weekly motivational interviewing sessions focusing on awareness, perceived benefits, self-efficacy, decision balance, empowerment, and commitment to behavior. Weekly DSM-5 Sleep Disorder assessments are also conducted.
Follow-up sessions continue during the second and third months to support maintenance of behavior change, with monthly evaluations using the PSQI and Stages of Change Inventory. Sleep diaries are used throughout to monitor participants' sleep patterns. The primary outcome is sleep quality, and secondary outcomes include self-efficacy and behavioral stage of change.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the experimental or control group using a parallel design. The experimental group will receive a Health Promotion Model-based oculomotor exercise program while the control group will receive no tervention and continue their usual daily activities. Both groups will be evaluated simultaneously at baseline and after the intervention using standardized scales for sleep quality and behavioral change.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Oculomotor Exercise ProgramParticipants in this group will receive a structured oculomotor exercise program designed according to the Health Promotion Model. The program includes oculomotor exercises performed three times a week and weekly motivational interviewing sessions to enhance self-efficacy and adherence. Sleep quality and behavioral change outcomes will be assessed at baseline and post-intervention. |
| Control Group | No intervention | –Participants in this group will not receive any intervention. They will continue their usual daily activities and will be evaluated using the same measurement tools and time points as the experimental group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Aged 65 years or older
- Residing in the nursing home for at least 6 months
- Scoring 4 or above on the Mini-Cog test
- Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 (indicating poor sleep quality)
- No diagnosis of psychiatric disorders such as depression, bipolar disorder, or schizophrenia
Key exclusion criteria (3 listed)
- Older adults unable to perform self-care independently
- Older adults with dizziness or balance problems
- Participants who are hospitalized for any reason during the follow-up or exercise sessions will be excluded from the study
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 |
|---|---|---|
| Oculomotor Exercise ProgramThis intervention is a structured oculomotor exercise program based on the Health Promotion Model, developed to improve sleep quality among older adults living in a nursing home. The program focuses on enhancing visual-motor coordination and relaxation through systematic eye movement exercises. Participants in the experimental group perform oculomotor exercises three times per week for four consecutive weeks under researcher supervision. The program includes educational support and brief motivational guidance to encourage adherence and consistency. Follow-up sessions are conducted during the following two months to monitor sleep patterns and maintain behavioral improvement. This intervention differs from traditional exercise programs by targeting the oculomotor system and incorporating health promotion principles to support better sleep and overall well-being in older adults. | Behavioural | Exercise Group |
Primary outcome
Sleep Quality
Time frame: Baseline, 4 weeks, 2 and 3 months after the intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, duration, and disturbances over the previous month. Higher scores indicate poorer sleep quality.
1 secondary outcome
Stage of Behavioral Change
Time frame: Baseline, 4 weeks, 2 and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to privacy and ethical restrictions
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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.
Hande sabandüzen, PhD Candidate principal investigator
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculomotor Exercise Program in people with Sleep Quality and Older Adults (65 Years and Older), run by Istanbul University - Cerrahpasa 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 10 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hande Sabandüzen, PhD Candidate (+905455693484, handesabanduzen@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Baseline, 4 weeks, 2 and 3 months after the intervention). 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 3 Dec 2025.