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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05390138
• Other study ID #: UW 21-135
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: Agnes YK Lai, PhD
• Phone: 852-3917-6328
• Email: agneslai[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

References & Publications (10)

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. Review. — View Citation

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. Review. English, Portuguese. — View Citation

Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Iftikhar IH, Kline CE, Youngstedt SD. Effects of exercise training on sleep apnea: a meta-analysis. Lung. 2014 Feb;192(1):175-84. Review. — View Citation

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. — View Citation

Suarez-Giron M, Garmendia O, Lugo V, Ruiz C, Salord N, Alsina X, Farré 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). pii: 00220-2019. doi: 10.1183/23120541.00220-2019. eCollection 2020 Jan. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in Duration of <90% oxygen desaturation	Duration of <90% oxygen desaturation will be assessed by sleep test.	Baseline, 4 months and 12 months
Secondary	Change in body weight	Body weight will be measured.	Baseline, 4 months and 12 months
Secondary	Change in body fat	Body fat will be measured.	Baseline, 4 months and 12 months
Secondary	Change in body neck circumference	Neck circumference will be measured.	Baseline, 4 months and 12 months
Secondary	Change in waist circumference	Waist circumference will be measured.	Baseline, 4 months and 12 months
Secondary	Change in hip circumference	Hip circumference will be measured.	Baseline, 4 months and 12 months
Secondary	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
Secondary	Change in Hand grip strength	Hand grip strength will be measured by a dynamometer.	Baseline, 4 months and 12 months
Secondary	Change in lower limb strength	Lower limb strength will be measured by a 30-second chair stand test.	Baseline, 4 months and 12 months
Secondary	Change in flexibility	Flexibility will be measured by a sit and reach test.	Baseline, 4 months and 12 months
Secondary	Change in balance	Balance will be measured by a single-leg stance test.	Baseline, 4 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in dietary habits	Dietary habits will be measured by 10-item dietary intake and practice questionnaire.	Baseline, 4 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Intervention credibility	The rationale of the delivered treatment and its ef?cacy 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