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

Poor Quality Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033601
• Other study ID #: 201812192RINC
• Status: Completed
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: April 2024
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Poor Quality Sleep

Intervention

Behavioral:
• Non-pharmacological intervention
The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Causal-pie analysis	The causal-pie analysis is used to elucidate the complex cause of poor sleep quality.	Up to 2 months