A Novel Strategy to Develop a Rapid Screen, Simple Subgrouping and Precise Intervention Model for Older Adults With Poor Sleep Quality

A Novel Strategy to Develop a Rapid Screen, Simple Subgrouping and Precise Intervention Model for Older Adults With Poor Sleep Quality: Integrating Latent Class Analysis With Causal- Pie Analysis to Implement Population-based Precision Medicine

Poor sleep quality is a major issue of public health in older adults. However, the underlying cause of poor sleep quality in older adults is multifactorial and complex. A highly accessible and effective instrument for screening and subgrouping older adults with poor sleep quality is warranted. In particular, the instrument is expected to suggest respective interventions. The present project will use two groups, including non-disabled and disabled older adults, to develop the short screen and subgrouping scale along with the respective intervention. During the first and second year of the project, we will apply the established non-disabled version of' the 'Short Screen and Subgrouping Scale' to screen and to subgroup older adults with poor sleep quality in non-disabled older population. Consecutively, the screened subgroups will be performed the causal-pie analysis to elucidate the complex cause of poor sleep quality. The number of participants is estimated as 500. Meanwhile, additional 500 disabled older adults, who will be invited in the hospital, will be used in the latent class analysis (LCA) to subgroup reasonable classes of poor sleep quality in disabled older adults. According to the result of LCA, the disabled version of the 'Short Screen and Subgrouping Scale' will be produced and relevant causal-pie analysis will be conducted accordingly. In the second and third year of this project, two randomized control trials (RCT) with two arms will be conducted, respectively. One arm is non-pharmacological intervention group (n=30) and the other is the control group (n=30). In the non-disabled older adults, the screened mild insomnia group, which has been defined in our pilot study, will be invited to attend the RCT. In the disabled older adults, after the LCA, the subgroup with mild symptoms will be considered to enter the RCT study phase. The intervention for both RCTs will be designed according to the result of causal-pie analysis. The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy. This 3-year project is expected to frame a population-level model of precision medicine, which targets poor sleep quality in older adults.

Study Overview

• Status: Completed
• Conditions: Poor Quality Sleep
• Intervention / Treatment: Behavioral: Non-pharmacological intervention

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The age range of patients are above 65 years old.
• Patients who have the ability to accept the exercise training.

Exclusion Criteria:

• Patients with obvious mental retardation or organic brain syndrome.
• Patients with dementia who cannot finish the questionnaire.
• Heart disease history.
• People who cannot apply to the demand.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group	Behavioral: Non-pharmacological intervention; The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.
Experimental: non-pharmacological intervention group	Behavioral: Non-pharmacological intervention; The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causal-pie analysis	The causal-pie analysis is used to elucidate the complex cause of poor sleep quality.	Up to 2 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: older adults; sleep quality; precision medicine; latent class analysis; causal-pie analysis; sleep medicine
• Other Study ID Numbers: 201812192RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No