NCT04262986

Brief Summary

Obstructive sleep apnea (OSA) is a common chronic disease and associated with cardiovascular and neurocognitive sequelae. Overweight is a common, reversible risk factor of OSA, and the rapid rise in obesity worldwide may lead to increases in OSA and related adverse health outcomes. Weight-loss interventions, especially comprehensive lifestyle interventions, are associated with improvements in OSA severity, cardiometabolic comorbidities, and quality of life. However, the intensive nature of these programmes often pose a barrier to adherence. Furthermore, although there is strong evidence to support the value of mobile text messaging to promote physical activity and healthy eating in clinical and community settings, messaging has rarely been applied in interventions for overweight OSA subjects. The proposed study aims to examine the feasibility of a brief lifestyle modification programme that makes use of smartphone technology (WhatsApp or WeChat) to empower subjects to start doing simple and easy-to-do exercises that can be easily integrated into daily life for gradual lifestyle change.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

February 6, 2020

Last Update Submit

April 11, 2022

Conditions

Keywords

Lifestyle modificationObstructive sleep apnoeaOverweight

Outcome Measures

Primary Outcomes (1)

  • Preference on physical activity

    Outcome-based questions with categorical choices

    Immediately after obtaining written consent

Secondary Outcomes (6)

  • Current physical activity practices

    Immediately after obtaining written consent

  • Preference on programme contents and information

    Immediately after obtaining written consent

  • Preference on m-Health information

    Immediately after obtaining written consent

  • Daytime Sleepiness

    Immediately after obtaining written consent

  • Sleep quality

    Immediately after obtaining written consent

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with obstructive sleep apnoea

You may qualify if:

  • Aged 18 years or above;
  • Performed sleep test in sleep laboratory; and
  • Mentally fit to provide informed consent and answer self-administered questionnaire.

You may not qualify if:

  • Those on CPAP or oral appliance treatment;
  • Diagnosed with psychiatric illness; or
  • Unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

  • Dobrosielski DA, Papandreou C, Patil SP, Salas-Salvado J. Diet and exercise in the management of obstructive sleep apnoea and cardiovascular disease risk. Eur Respir Rev. 2017 Jun 28;26(144):160110. doi: 10.1183/16000617.0110-2016. Print 2017 Jun 30.

    PMID: 28659501BACKGROUND
  • Hudgel DW, Patel SR, Ahasic AM, Bartlett SJ, Bessesen DH, Coaker MA, Fiander PM, Grunstein RR, Gurubhagavatula I, Kapur VK, Lettieri CJ, Naughton MT, Owens RL, Pepin JL, Tuomilehto H, Wilson KC; American Thoracic Society Assembly on Sleep and Respiratory Neurobiology. The Role of Weight Management in the Treatment of Adult Obstructive Sleep Apnea. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 15;198(6):e70-e87. doi: 10.1164/rccm.201807-1326ST.

    PMID: 30215551BACKGROUND
  • Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.

    PMID: 25785892BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveOverweight

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Agnes YK Lai, PhD

    School of Nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

Mary Ip, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

May 11, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Subject consent did not include sharing personal information to other researchers.

Locations