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

A Smart Sleep Apnea Self-management Support Programme(4S) to Improve Apnea Severity and Cardiovascular Health - A Pragmatic Randomized Controlled Trial With Mixed-method Evaluation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Smart Sleep Apnea Self-management Support Programme (4S); Behavioral: General Hygiene Information (GH)

Detailed Description

OSA is a chronic disease with high prevalence that parallels with increasing obesity. OSA affects around 12% and 24% of adults in Hong Kong and China Mainland, respectively. Chronic intermittent hypoxia and sleep fragmentation of OSA leads to cardiometabolic and neurocognitive sequelae (e.g. hypertension, diabetes, daytime sleepiness and depression). Long-term, multidisciplinary management involving patients in decision-making of treatment strategies, shifting from positive airway pressure (PAP) device-focused to the patient-centered chronic care model has been suggested.

Mobile instant messaging (such as WhatsApp/WeChat) are popular and inexpensive for interactive messaging. Smartphone-based self-management interventions were reported improved self-efficacy and clinical outcomes in patients with chronic diseases. The investigator only found one mobile health application to support CPAP therapy for OSA and one ongoing trial of OSA self-management telematic support to improve CPAP adherence. There is underutilization of mobile technology in patient-centered self-management programmes to improve PAP treatment and lifestyle modifications in OSA.

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. Questionnaire and simple fitness assessment will be used to assess the effectivness of the intervention at 4-month and 12-month follow-up. Focus group interview will be conducted to collect qualiatative feedback on the intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes YK Lai, PhD; Phone Number: 852-3917-6328; Email: agneslai@hku.hk
• Study Contact Backup: Name: George Cheung, MPhil; Phone Number: 852-3917-7583; Email: ocgeorge@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Sleep Apnea Self-management Support Programme (4S); 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); 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.; Other Names: 4S group
Placebo Comparator: General Hygiene Information (GH); Patients will receive general hygiene information (GH) in addition to usual care	Behavioral: General Hygiene Information (GH); 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.; Other Names: GH group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in apnea hypopnea index	Apnea hypopnea index will be assessed 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 and 12 months
Change in Duration of <90% oxygen desaturation	Duration of <90% oxygen desaturation will be assessed by sleep test.	Baseline, 4 months and 12 months
Change in body weight	Body weight will be measured.	Baseline, 4 months and 12 months
Change in body fat	Body fat will be measured.	Baseline, 4 months and 12 months
Change in body neck circumference	Neck circumference will be measured.	Baseline, 4 months and 12 months
Change in waist circumference	Waist circumference will be measured.	Baseline, 4 months and 12 months
Change in hip circumference	Hip circumference will be measured.	Baseline, 4 months and 12 months
Change objective physical activity level	Steps count and acceleration pattern of physical activity will be measured by a 7-day waist-worn accelerometer.	Baseline, 4 months and 12 months
Change in Hand grip strength	Hand grip strength will be measured by a dynamometer.	Baseline, 4 months and 12 months
Change in lower limb strength	Lower limb strength will be measured by a 30-second chair stand test.	Baseline, 4 months and 12 months
Change in flexibility	Flexibility will be measured by a sit and reach test.	Baseline, 4 months and 12 months
Change in balance	Balance will be measured by a single-leg stance test.	Baseline, 4 months and 12 months
Change in daytime sleepiness	Daytime sleepiness will be measured by a 8-item Epworth Sleepiness Scale with a 3-point Likert scale. Total scores range from 0 to 24. Higher scores reflect greater daytime sleepiness.	Baseline, 4 months and 12 months
Change in sleep quality	Sleep quality will be measured by a 7-item Insomnia Severity Index with a 4-point Likert scale. Total scores range from 0 to 28. Higher scores reflect greater severity of insomnia.	Baseline, 4 months and 12 months
Change in functional outcomes of sleep	Functional outcomes of sleep will be measured by 10-item Functional Outcomes of Sleep Questionnaire with a 4-point Likert scale. Total scores range from 10 to 40. Higher scores reflect better functional outcomes of sleep.	Baseline, 4 months and 12 months
Change in quality of life	Quality of life will be measured by 5-item EuroQol 5-Dimension questionnaire. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Baseline, 4 months and 12 months
Change in anxiety symptoms	Anxiety symptoms will be measured by Generalised Anxiety Disorder Assessment (GAD-7) with a 3-point Likert scale. Total scores range from 0 to 21. Higher scores reflect more higher anxiety symptoms.	Baseline, 4 months and 12 months
Change in depressive symptoms	Depressive symptoms will be measured by 9-item Patient Health Questionnaire-9 (PHQ-9) with a 3-point Likert scale. Total scores range from 0 to 27. Higher scores reflect more higher depressive symptoms.	Baseline, 4 months and 12 months
Change in subjective happiness	Subjective happiness will be measured by 4-item Subjective Happiness Scale with a 7-point Likert scale. Total scores range from 4 to 28. The highest scores reflect greater happiness.	Baseline, 4 months and 12 months
Change in subjective physical activity level	Subjective physical activity level will be measured by 8-item International Physical Assessment Questionnaire -short version	Baseline, 4 months and 12 months
Change in dietary habits	Dietary habits will be measured by 10-item dietary intake and practice questionnaire.	Baseline, 4 months and 12 months
Change in self-efficacy in CPAP use	Self-efficacy in CPAP use will be measured by a 26-item Self-efficacy Measure for Sleep Apnea. Each Item ranges from 1 to 4: Higher scores indicate greater perceived self-efficacy, greater perceived response efficacy, and higher perceived susceptibility.	Baseline, 4 months and 12 months
Change in exercise and dietary control self-efficacy	Exercise and dietary control self-efficacy will be measured by outcome-based questionnaire. Each item ranges from 1-10. The higher scores indicate higher self-efficacy	Baseline, 4 months and 12 months
Change in perceived support from family and peers	Perceived support from family and peers measured by a 8-item Multidimensional Scale of Perceived Social Support with a 7-point Likert scale. Total scores for both family and peer subscales range from 4 to 28. Higher scores reflect better perceived social support.	Baseline, 4 months and 12 months
Change in patient activation	Knowledge, skills and confidence in self-management were measured by a 13-item Patient Activation Measure Scale. The total score ranges from 0 (no activation) to 100 (high activation), with higher scores denoting the better patient activation.	Baseline, 4 months and 12 months
Intervention credibility	The rationale of the delivered treatment and its efficacy to alleviate sleep apnea will be measured using the 4-item Credibility of Treatment Rating Scale. Each item ranges from 1-6. The higher scores indicate higher credibility.	4 months and 12 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): September 20, 2024
• Study Completion (Anticipated): December 20, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: UW 21-135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Need to obtain consent from patients before agreeing to share individual participants data.
• IPD Sharing Time Frame: When study finished
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No