NCT02260843

Brief Summary

Elderly insomnia is a serious public health problem. Current conventional approaches for treating insomnia are not suitable or effective in elderly population. It has been previously demonstrated that Tai Chi has definite advantages to be developed as self-help therapy in older adults and has been preliminarily demonstrated to improve sleep in older people. This project aims to evaluate the efficacy of Tai Chi training on alleviating chronic insomnia in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

June 11, 2014

Last Update Submit

July 21, 2020

Conditions

InsomniaPoor Sleeping Quality

Keywords

InsomniaSleepingQuality

Outcome Measures

Primary Outcomes (12)

  • Actigraphy-measured sleep onset latency

    Objectively measured sleep onset latency (min)

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured sleep efficiency

    Objectively measured sleep efficiency (%)

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured wake time after sleep onset

    Objectively measured wake time after sleep onset (min)

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured total sleep time

    Objectively measured total sleep time (min)

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured number of awakening

    Objectively measured number of awakening (number of times) after sleep onset

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured average wake time

    Objectively measured average wake time (min) of all awaken time after sleep onset

    Immediately after completion of the 12 weeks intervention

  • Actigraphy-measured sleep onset latency

    Objectively measured sleep onset latency (min)

    24 months after the completion of intervention

  • Actigraphy-measured Sleep efficiency

    Objectively measured sleep efficiency (%)

    24 months after the completion of intervention

  • Actigraphy-measured wake time after sleep onset

    Objectively measured wake time after sleep onset (min)

    24 months after the completion of intervention

  • Actigraphy-measured total sleep time

    Objectively measured total sleep time (min)

    24 months after the completion of intervention

  • Actigraphy-measured number of awakening

    Objectively measured number of awakening (number of times) after sleep onset

    24 months after the completion of intervention

  • Actigraphy-measured average wake time

    Objectively measured average wake time (min) of all awaken time after sleep onset

    24 months after the completion of intervention

Secondary Outcomes (6)

  • Score of Pittsburgh Sleep Quality Index

    Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention

  • Change in dose of Sleep Medication

    Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention

  • Score of Insomnia Severity Index

    Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention

  • 7-day Sleep Diary

    Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention

  • Treatment response rate

    Immediately after completion of the 12 weeks intervention and 24 months after the completion of intervention

  • +1 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Subjects in this group do not received any intervention.

Tai Chi Intervention

ACTIVE COMPARATOR

Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks

Other: Tai Chi Intervention

Generic Fitness Intervention

PLACEBO COMPARATOR

Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks

Other: Generic Fitness

Interventions

Generic FitnessOTHER

Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks

Generic Fitness Intervention
Tai Chi InterventionOTHER

Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks

Tai Chi Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • ethnic Chinese
  • fulfill the DSM-V criteria for chronic insomnia including difficulties to initiate sleep, maintain sleep or non-restorative sleep with complaint of impairment of daytime functioning, sleep difficulty occurs at least 3 nights per week and is present for at least three months.

You may not qualify if:

  • cannot walk without assistive tool (e.g., cane)
  • any serious somatic condition that prevent participation for Tai Chi/generic fitness activities
  • current regular practicing of moderate exercise training or Tai Chi (\>3 times a week of \>30-min per session)
  • any serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases)
  • under treatment of serious diseases known to affect sleep (e.g., cancer chemotherapy)
  • any chronic pain disorders known to affect sleep.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, 852, China

Location

The University of Hong Kong

Hong Kong, Hong Kong, 852, China

Location

The Hong Kong Polytechnic University

Hong Kong, 852, China

Location

Related Publications (1)

  • Siu PM, Yu AP, Tam BT, Chin EC, Yu DS, Chung KF, Hui SS, Woo J, Fong DY, Lee PH, Wei GX, Irwin MR. Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2037199. doi: 10.1001/jamanetworkopen.2020.37199.

    PMID: 33587135DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Parco MF Siu, PHD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 11, 2014

First Posted

October 9, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2017

Study Completion

August 1, 2018

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), as well as the study protocol and the statistical analysis plan, will be shared, beginning 3 months and ending 5 years following publication of the Article. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 3 months and ending 5 years following publication of the Article
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to pmsiu@hku.hk to gain access, and data requestors will need to sign a data-access agreement.

Locations

CN(3)