NCT07261124

Brief 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. 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?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 23, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

November 23, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

sleep qualityhealth promotionEye Movementsnursingaged

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 4 weeks, 2 and 3 months after the intervention

Secondary Outcomes (1)

  • Stage of Behavioral Change

    Baseline, 4 weeks, 2 and 3 months after the intervention

Study Arms (2)

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.

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.

Interventions

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.

Exercise Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A Nursing home facility in Istanbul

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Hande sabandüzen, PhD Candidate

    İstanbul University-Cerrahpaşa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hande Sabandüzen, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 3, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Due to privacy and ethical restrictions

Locations