Obstructive Sleep ApneaNCT03189940
Lifestyle Modification Using an App in OSA
A study testing Life style modification by using and app with a wrist-worn activity tracker and Conventional Life style modification in people with Obstructive Sleep Apnea and Obesity, run by Seoul National University Hospital.
Trial summary
This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- What is being tested?
- Life style modification by using and app with a wrist-worn activity tracker and Conventional Life style modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2016to 18 Nov 2016
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI > 23 Kg/m2
Who cannot join
- ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant
About this study
Official title: Effect of Lifestyle Modification Using Smartphone Application on Weight Reduction and Obstructive Sleep Apnea
This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged > 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Being tested
- Life style modification by using and app with a wrist-worn activity tracker, Conventional Life style modification
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style modification by using and app with a wrist-worn activity trackerBehavioural
The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data.
Conventional Life style modificationBehavioural
Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment
| Study group | Role | What they receive |
|---|---|---|
| App user group | Active comparator | Not described Receives: Behavioral: Life style modification by using and app with a wrist-worn activity tracker |
| Control group | Sham comparator | Control participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls Receives: Behavioral: Conventional Life style modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body weight
body weight measurement and calculate into body mass index (BMI)
Measured: base line and after 4weeks of life style modiciation
Secondary outcomes (5)
apnea hypopnea index (AHI)
number of apnea and or hypopnea event per hour during sleep
Measured: base line and after 4weeks of life style modiciation
respiratory distress index (RDI)
AHI + number of respiratory effor related arousal (RERA) per hour during sleep
Measured: base line and after 4weeks of life style modiciation
oxygen desaturation index (ODI)
number of desaturation event (peripheral oxygen satuation less than 90%) per hour during sleep
Measured: base line and after 4weeks of life style modiciation
sleep time proportion with snoring loudness > 45dB
total duration of the snoring loudness >45 dB devided by the total sleep time (%)
Measured: base line and after 4weeks of life style modiciation
lowest oxygen saturation
the degree of the lowest oxygen saturation measured during sleep
Measured: base line and after 4weeks of life style modiciation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start20 Jun 2016
- Primary completion26 Jul 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Whun Kim, Seoul National University Hospital
- Investigators
- Jeong-Whun Kim, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189940
- Sponsor's protocol ID
- B-1504-296-302
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the individual data is confidential according to the hospital's policy
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Modification Using Smartphone Application on Weight Reduction and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03189940
- Acronym / sponsor ID
- B-1504-296-302
- Conditions
- Obstructive Sleep Apnea, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 26 Jul 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 16 Jun 2017 (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.
This study aimed to investigate the effects of a mobile phone app linked to hospital electronic medical record (EMR) system on weight reduction and obstructive sleep apnea (OSA). Adults aged > 20 years with witnessed snoring or sleep apnea from a sleep clinic of a tertiary center were prospectively enrolled, and the participats were randomized into app user and control groups. The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. In the control group, the lifestyle modification performed as the usual practice. All participants underwent Watch PAT and body mass index (BMI) measurement twice: on enrollment; and after 4-weeks follow up. Changes of BMI, and parameters of sleep related breathing were analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App user group | Active comparator | Behavioral: Life style modification by using and app with a wrist-worn activity tracker |
| Control group | Sham comparator | Behavioral: Conventional Life style modificationControl participants, the physicians could assess the lifestyle and recommend further lifestyle modification only on the basis of the participants' recalls |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ᆞ patients must agree to participate in our clinical study ᆞ patients without severe cardiopulmonary disease ᆞ patients must be with BMI > 23 Kg/m2
Key exclusion criteria (1 listed)
- ᆞ patients who did not agree ᆞ patients with severe cardiopulmonary disease ᆞpatients who are under treatment using a continuous positive airway pressure device or a mandibular advancement device ᆞ patients who were pregnant
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 |
|---|---|---|
| Life style modification by using and app with a wrist-worn activity trackerThe mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data. | Behavioural | App user group |
| Conventional Life style modificationPhysician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment | Behavioural | Control group |
Primary outcome
changes in body weight
Time frame: base line and after 4weeks of life style modiciation
body weight measurement and calculate into body mass index (BMI)
5 secondary outcomes
apnea hypopnea index (AHI)
Time frame: base line and after 4weeks of life style modiciation
respiratory distress index (RDI)
Time frame: base line and after 4weeks of life style modiciation
oxygen desaturation index (ODI)
Time frame: base line and after 4weeks of life style modiciation
sleep time proportion with snoring loudness > 45dB
Time frame: base line and after 4weeks of life style modiciation
lowest oxygen saturation
Time frame: base line and after 4weeks of life style modiciation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No. the individual data is confidential according to the hospital's policy
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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.
Jeong-Whun Kim, MD, PhD study director
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Life style modification by using and app with a wrist-worn activity tracker and Conventional Life style modification in people with Obstructive Sleep Apnea and Obesity, run by Seoul National University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in body weight (time frame: base line and after 4weeks of life style modiciation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017.