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

NCT04033601 | Completed

• 1 other identifier: 201812192RINC
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poor Quality Sleep

Keywords

latent class analysis; causal-pie analysis; sleep quality; precision medicine; older adults; sleep medicine

Outcome Measures

Primary Outcomes (1)

• Causal-pie analysis

  The causal-pie analysis is used to elucidate the complex cause of poor sleep quality.

  Up to 2 months

Study Arms (2)

non-pharmacological intervention group

EXPERIMENTAL

Behavioral: Non-pharmacological intervention

control group

EXPERIMENTAL

Behavioral: Non-pharmacological intervention

Interventions

Non-pharmacological intervention BEHAVIORAL

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

control group; non-pharmacological intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: July 13, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)