A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea

NCT05390138 | Unknown DMC

• 1 other identifier: UW 21-135
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

OSA is a chronic disease with high prevalence that parallels with increasing obesity. Self-management programmes are perceived to be cost-effective in long-term OSA patient care and can supplement regular medical treatments. The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in apnea hypopnea index

  Apnea hypopnea index will be asssessed by sleep test. The apnea hypopnea index is the number of times of apnea or hypopnea during one night, divided by the hours of sleep. The higher the apnea hypopnea index, the more severe sleep apnea is.

  Baseline, 4 months

Secondary Outcomes (26)

• Change in apnea hypopnea index

  Baseline and 12 months

• Change in Duration of <90% oxygen desaturation

  Baseline, 4 months and 12 months

• Change in body weight

  Baseline, 4 months and 12 months

• Change in body fat

  Baseline, 4 months and 12 months

• Change in body neck circumference

  Baseline, 4 months and 12 months

Study Arms (2)

Smart Sleep Apnea Self-management Support Programme (4S)

EXPERIMENTAL

Patients will receive Smart Sleep Apnea Self-management Support Programme (4S) in addition to usual care

Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)

General Hygiene Information (GH)

PLACEBO COMPARATOR

Patients will receive general hygiene information (GH) in addition to usual care

Behavioral: General Hygiene Information (GH)

Interventions

Smart Sleep Apnea Self-management Support Programme (4S) BEHAVIORAL

The experimental group will receive usual care and Smart Sleep Apnea Self-management Support Programme (4S). The 4S includes two interview sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to self-management. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

Also known as: 4S group

Smart Sleep Apnea Self-management Support Programme (4S)

General Hygiene Information (GH) BEHAVIORAL

The control group will receive usual care and general hygiene information (GH). The GH includes two GH sessions, instant messages, phone calls, continuous personalized chat-based messaging and phone call support and hotline services in relation to general hygiene information. An e-platform will be used for self-monitoring and group sharing sessions will be conducted for experience sharing.

Also known as: GH group

General Hygiene Information (GH)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years and above;
• diagnosis of moderate to severe obstructive sleep apnea (AHI≥15);
• physically inactive (self-reported moderate physical activity per week of \<150 minutes);
• overweight (BMI≥23 kg/m2);
• mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
• able to speak and read Chinese;
• willing to complete the questionnaires and assessments;
• has a smartphone with instant messaging function (eg. WhatsApp/WeChat); and
• willing to give informed consent.

You may not qualify if:

• sleep disorder other than OSA;
• clinically significant psychiatric, neurological, or medical disorder other than OSA; and
• use of prescription drugs or clinically significant drugs affecting sleep.

Sponsors & Collaborators

• The University of Hong Kong: lead

Related Publications (10)

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

• Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.

  PMID: 19960649 BACKGROUND

• Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.

  PMID: 28117479 BACKGROUND

• Iftikhar IH, Kline CE, Youngstedt SD. Effects of exercise training on sleep apnea: a meta-analysis. Lung. 2014 Feb;192(1):175-84. doi: 10.1007/s00408-013-9511-3.

  PMID: 24077936 BACKGROUND

• Aiello KD, Caughey WG, Nelluri B, Sharma A, Mookadam F, Mookadam M. Effect of exercise training on sleep apnea: A systematic review and meta-analysis. Respir Med. 2016 Jul;116:85-92. doi: 10.1016/j.rmed.2016.05.015. Epub 2016 May 21.

  PMID: 27296826 BACKGROUND

• Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med. 2007;5(2):131-46. doi: 10.1080/15402000701190622.

  PMID: 17441783 BACKGROUND

• Dickerson SS, Jungquist C, TenBrock E, Aquilina A, Smith P, Sabbah EA, Alameri R, Dean G. Feasibility Testing of a Self-Management Program Book to Improve Adherence to PAP in Persons Newly Diagnosed With Sleep Apnea. Behav Sleep Med. 2018 Sep-Oct;16(5):413-426. doi: 10.1080/15402002.2016.1228644. Epub 2016 Sep 23.

  PMID: 27660897 BACKGROUND

• Dickerson SS, TenBrock E, Smith P, Kwon M, Chacko T, Li CS, Dean GE. Mixed methods feasibility study of Breathe2Sleep a peer modeling approach to PAP self-management. Heart Lung. 2020 Nov-Dec;49(6):949-958. doi: 10.1016/j.hrtlng.2020.04.015. Epub 2020 May 28. No abstract available.

  PMID: 32473747 BACKGROUND

• Zimbudzi E, Lo C, Misso ML, Ranasinha S, Kerr PG, Teede HJ, Zoungas S. Effectiveness of self-management support interventions for people with comorbid diabetes and chronic kidney disease: a systematic review and meta-analysis. Syst Rev. 2018 Jun 13;7(1):84. doi: 10.1186/s13643-018-0748-z.

  PMID: 29898785 BACKGROUND

• Suarez-Giron M, Garmendia O, Lugo V, Ruiz C, Salord N, Alsina X, Farre R, Montserrat JM, Torres M. Mobile health application to support CPAP therapy in obstructive sleep apnoea: design, feasibility and perspectives. ERJ Open Res. 2020 Feb 10;6(1):00220-2019. doi: 10.1183/23120541.00220-2019. eCollection 2020 Jan.

  PMID: 32055630 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Agnes YK Lai, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

852-3917-6328; agneslai@hku.hk

George Cheung, MPhil

CONTACT

852-3917-7583; ocgeorge@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor did not aware of which groups the patients belongs to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a 2-group randomisation controlled trial with 4-month and 12-month follow-up. The Experimental group will receive 4S intervention in relation to self-management and the Control group will receive general hygiene information.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 25, 2022
• Study Start: June 1, 2022
• Primary Completion: September 20, 2024
• Study Completion: December 20, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When study finished
• Access Criteria: The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Mr George Cheung (email ocgeorge@hku.hk), (School of Nursing, The University of Hong Kong) for further information.