Obstructive Sleep ApneaNCT05390138
A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea
A study testing Smart Sleep Apnea Self-management Support Programme (4S) and General Hygiene Information (GH) in people with Obstructive Sleep Apnea, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Smart Sleep Apnea Self-management Support Programme (4S) and General Hygiene Information (GH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- willing to complete the questionnaires and assessments;
- has a smartphone with instant messaging function (eg. WhatsApp/WeChat); and
- willing to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Smart Sleep Apnea Self-management Support Programme (4S), General Hygiene Information (GH)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Sleep Apnea Self-management Support Programme (4S)Behavioural
Also called 4S group
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)Behavioural
Also called GH group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: General Hygiene Information (GH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months
Secondary outcomes (26)
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.
Measured: Baseline and 12 months
Change in Duration of <90% oxygen desaturation
Duration of <90% oxygen desaturation will be assessed by sleep test.
Measured: Baseline, 4 months and 12 months
Change in body weight
Body weight will be measured.
Measured: Baseline, 4 months and 12 months
Change in body fat
Body fat will be measured.
Measured: Baseline, 4 months and 12 months
Change in body neck circumference
Neck circumference will be measured.
Measured: Baseline, 4 months and 12 months
Change in waist circumference
Waist circumference will be measured.
Measured: Baseline, 4 months and 12 months
Change in hip circumference
Hip circumference will be measured.
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.
Measured: Baseline, 4 months and 12 months
Change in Hand grip strength
Hand grip strength will be measured by a dynamometer.
Measured: Baseline, 4 months and 12 months
Change in lower limb strength
Lower limb strength will be measured by a 30-second chair stand test.
Measured: Baseline, 4 months and 12 months
Change in flexibility
Flexibility will be measured by a sit and reach test.
Measured: Baseline, 4 months and 12 months
Change in balance
Balance will be measured by a single-leg stance test.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 4 months and 12 months
Change in dietary habits
Dietary habits will be measured by 10-item dietary intake and practice questionnaire.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
- Investigators
- Agnes YK Lai, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390138
- Sponsor's protocol ID
- UW 21-135
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Need to obtain consent from patients before agreeing to share individual participants data.
Publications
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.
PubMed 31300334Epstein 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.
PubMed 19960649Andrade 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.
PubMed 28117479Iftikhar 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.
PubMed 24077936Aiello 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.
PubMed 27296826Stepnowsky 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.
PubMed 17441783Dickerson 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.
PubMed 27660897Dickerson 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.
PubMed 32473747Zimbudzi 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.
PubMed 29898785Suarez-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.
PubMed 32055630
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05390138
- Acronym / sponsor ID
- UW 21-135
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smart Sleep Apnea Self-management Support Programme (4S) | Experimental | Behavioral: Smart Sleep Apnea Self-management Support Programme (4S)Patients will receive Smart Sleep Apnea Self-management Support Programme (4S) in addition to usual care |
| General Hygiene Information (GH) | Placebo comparator | Behavioral: General Hygiene Information (GH)Patients will receive general hygiene information (GH) in addition to usual care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Sleep Apnea Self-management Support Programme (4S)Also: 4S groupThe 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. | Behavioural | Smart Sleep Apnea Self-management Support Programme (4S) |
| General Hygiene Information (GH)Also: GH groupThe 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. | Behavioural | General Hygiene Information (GH) |
Primary outcome
Change in apnea hypopnea index
Time frame: Baseline, 4 months
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.
26 secondary outcomes
Change in apnea hypopnea index
Time frame: Baseline and 12 months
Change in Duration of <90% oxygen desaturation
Time frame: Baseline, 4 months and 12 months
Change in body weight
Time frame: Baseline, 4 months and 12 months
Change in body fat
Time frame: Baseline, 4 months and 12 months
Change in body neck circumference
Time frame: Baseline, 4 months and 12 months
Change in waist circumference
Time frame: Baseline, 4 months and 12 months
Change in hip circumference
Time frame: Baseline, 4 months and 12 months
Change objective physical activity level
Time frame: Baseline, 4 months and 12 months
Change in Hand grip strength
Time frame: Baseline, 4 months and 12 months
Change in lower limb strength
Time frame: Baseline, 4 months and 12 months
Change in flexibility
Time frame: Baseline, 4 months and 12 months
Change in balance
Time frame: Baseline, 4 months and 12 months
Change in daytime sleepiness
Time frame: Baseline, 4 months and 12 months
Change in sleep quality
Time frame: Baseline, 4 months and 12 months
Change in functional outcomes of sleep
Time frame: Baseline, 4 months and 12 months
Change in quality of life
Time frame: Baseline, 4 months and 12 months
Change in anxiety symptoms
Time frame: Baseline, 4 months and 12 months
Change in depressive symptoms
Time frame: Baseline, 4 months and 12 months
Change in subjective happiness
Time frame: Baseline, 4 months and 12 months
Change in subjective physical activity level
Time frame: Baseline, 4 months and 12 months
Change in dietary habits
Time frame: Baseline, 4 months and 12 months
Change in self-efficacy in CPAP use
Time frame: Baseline, 4 months and 12 months
Change in exercise and dietary control self-efficacy
Time frame: Baseline, 4 months and 12 months
Change in perceived support from family and peers
Time frame: Baseline, 4 months and 12 months
Change in patient activation
Time frame: Baseline, 4 months and 12 months
Intervention credibility
Time frame: 4 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 31300334Benjafield 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.
- Background: PubMed 19960649Epstein 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.
- Background: PubMed 28117479Andrade 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.
- Background: PubMed 24077936Iftikhar 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.
- Background: PubMed 27296826Aiello 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.
- Background: PubMed 17441783Stepnowsky 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.
- Background: PubMed 27660897Dickerson 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.
- Background: PubMed 32473747Dickerson 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.
- Background: PubMed 29898785Zimbudzi 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.
- Background: PubMed 32055630Suarez-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.
- Individual participant dataSharing planned: Yes. Need to obtain consent from patients before agreeing to share individual participants data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YK Lai, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Smart Sleep Apnea Self-management Support Programme (4S) and General Hygiene Information (GH) in people with Obstructive Sleep Apnea, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes YK Lai, PhD (852-3917-6328, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea hypopnea index (time frame: Baseline, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390138, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.