Obstructive Sleep ApneaNCT04563169

Video Consultation in CPAP for Patients With Obstructive Sleep Apnea

A study testing Video consultation in people with Obstructive Sleep Apnea, run by Rijnstate Hospital at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this study is to evaluate the effects of video consultation versus face-to-face consultation for patients with obstructive sleep apnea on patients' CPAP use (minutes/per night), self-efficacy, risk outcomes, outcome expectancies, experiences with technology and, patients' and nurses' satisfaction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Video consultation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteNetherlands
Study dates: 2 Jan 2019to 9 Dec 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Older than 18 years
Diagnosed with obstructive sleep apnea
AHI > 15
Requiring CPAP treatment
No history of CPAP treatment
Having access to a tablet or smartphone
Proficiency of the Dutch language

Who cannot join

Psychiatric or cognitive disorder

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Rijnstate
Arnhem, 6815AD

Other trials in Netherlands

About this study

Official title: Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.

Read the detailed description

This study is a non-blinded randomized controlled trial with an intervention group (video consultations) and a usual care group (face-to-face consultations), with assessements after 1, 2, 3, 4, 12 and 24 weeks.

Patients were recruited from a large teaching hospital (Rijnstate, hospital), and included from January 2, 2019 until June 26, 2019.In total, 140 patients were randomized, (1:1 allocation).

Conditions: Obstructive Sleep Apnea
Being tested: Video consultation
Keywords: Video consultation, E-Health, CPAP, Randomized Controlled Trial
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.

Video consultationOther
The first video consultation with a nurse was planned one week after start with CPAP. Three focus points were discussed during the consultations: 1) adherence (>6 hours per night); 2) rest AHI < 5 (or <10 if age >70), and 3) (improvements in) complaints. If these objectives were achieved after one week, a new consultation was planned three weeks later (four weeks after start). As long as these objectives were not achieved, video consultations were planned weekly (until after four weeks).

Study groups in NCT04563169
Study group	Role	What they receive
Video consultation	Experimental	Patients in the video consultation group will receive video consultations. Receives: Other: Video consultation
Face-to-Face consultation	No intervention	Patients in the usual care group will receive face-to-face consultations.

What is being measured

The primary outcome is the main question the study is designed to answer.

CPAP use
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
Measured: Week 1 through week 4
CPAP use
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
Measured: Week 4 through week 12

Secondary outcomes (12)

CPAP adherence
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
Measured: Week 1 through week 4
CPAP adherence
CPAP use for at least 5 nights per week for at least 4 hours per night. Extracted from Encore Anywhere.
Measured: Week 4 through week 24
Self-efficacy
Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated with a 4 point scale, varying from 1 (not at all true) to 4 (very true).
Measured: Baseline
Self-efficacy
Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).
Measured: Week 4
Outcome expectancies
Assessed with Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).
Measured: Baseline
Outcome expectancies
Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (not at all true) to 4 (very true).
Measured: Week 4
Risk perception
Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high).
Measured: Baseline
Risk perception
Assessed with Self-Efficacy Measure for Sleep Apnea questionnaire. Items were rated on a 4 point scale, varying from 1 (very low) to 4 (very high).
Measured: Week 4
Expectations with video consultation
Questions based on constructs of the Unified Theory of Acceptance and Use of Technology. Items were rated on a 7 point scale, varying from 1 (totally disagree) to 7 (totally agree).
Measured: Baseline
Experiences video consultation
Questions based on constructs of the Unified Theory of Acceptance and Use of Technology (intervention group only). Items were rated on a 7 point scale, varying from 1 (totally disagree) to 7 (totally agree).
Measured: Week 4
Satisfaction patients
Questionnaires were used to assess satisfaction about consultations, number of consultations, received information, satisfaction with video consultation (intervention group only) and suggestions for improvement of the use of video consultation (open ended question). Items were rated on a 5 point scale, varying from 1 (totally disagree) to 5 (totally agree). Overall satisfaction was rated on a scale varying from 1 (not satisfied) to 10 (very satisfied).
Measured: Week 4
Satisfaction patients
Satisfaction with video consultation, benefits (eg, time and efficiency) and integration in work process. Items were rated on a 5 point scale, varying from 1 (totally disagree) to 5 (totally agree). Overall satisfaction was rated on a scale varying from 1 (not satisfied) to 10 (very satisfied). Suggestions for improvement were assessed using an open question
Measured: After intervention completion, up to 8 months (after start).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20199 Dec 2019

First posted24 Sep 2020
Study start2 Jan 2019
Primary completion9 Dec 2019
Study completion9 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Controlled Trial
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04563169
Sponsor's protocol ID: 2018-1165
Status last verified: Sep 2020
First submitted: 16 Sep 2020
Last updated: 24 Sep 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kooij L, Vos PJ, Dijkstra A, Roovers EA, van Harten WH. Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial. JMIR Form Res. 2021 May 11;5(5):e20779. doi: 10.2196/20779.
PubMed 33973866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT04563169
Acronym / sponsor ID: 2018-1165
Conditions: Obstructive Sleep Apnea
Keywords: Video consultation, E-Health, CPAP, Randomized Controlled Trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Rijnstate HospitalUniversity, hospital or other
Study start: 2 Jan 2019 (actual)
Primary completion: 9 Dec 2019 (actual)
Study completion: 9 Dec 2019 (actual)
First posted: 24 Sep 2020 (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.

Detailed description

Patients were recruited from a large teaching hospital (Rijnstate, hospital), and included from January 2, 2019 until June 26, 2019.In total, 140 patients were randomized, (1:1 allocation).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Controlled Trial

Arm	Type	Receives
Video consultation	Experimental	Other: Video consultationPatients in the video consultation group will receive video consultations.
Face-to-Face consultation	No intervention	–Patients in the usual care group will receive face-to-face consultations.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Older than 18 years
Diagnosed with obstructive sleep apnea
AHI > 15
Requiring CPAP treatment
No history of CPAP treatment

Key exclusion criteria (1 listed)

Psychiatric or cognitive disorder

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
Video consultationThe first video consultation with a nurse was planned one week after start with CPAP. Three focus points were discussed during the consultations: 1) adherence (>6 hours per night); 2) rest AHI < 5 (or <10 if age >70), and 3) (improvements in) complaints. If these objectives were achieved after one week, a new consultation was planned three weeks later (four weeks after start). As long as these objectives were not achieved, video consultations were planned weekly (until after four weeks).	Other	Video consultation

Primary outcome

CPAP use
Time frame: Week 1 through week 4
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.
CPAP use
Time frame: Week 4 through week 12
Continuous Airway Pressure use (minutes/night), extracted from Encore Anywhere.

12 secondary outcomes

CPAP adherence
Time frame: Week 1 through week 4
CPAP adherence
Time frame: Week 4 through week 24
Self-efficacy
Time frame: Baseline
Self-efficacy
Time frame: Week 4
Outcome expectancies
Time frame: Baseline
Outcome expectancies
Time frame: Week 4
Risk perception
Time frame: Baseline
Risk perception
Time frame: Week 4
Expectations with video consultation
Time frame: Baseline
Experiences video consultation
Time frame: Week 4
Satisfaction patients
Time frame: Week 4
Satisfaction patients
Time frame: After intervention completion, up to 8 months (after start).

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 24 Sep 2020.
Derived from this study: PubMed 33973866Kooij L, Vos PJ, Dijkstra A, Roovers EA, van Harten WH. Video Consultation as an Adequate Alternative to Face-to-Face Consultation in Continuous Positive Airway Pressure Use for Newly Diagnosed Patients With Obstructive Sleep Apnea: Randomized Controlled Trial. JMIR Form Res. 2021 May 11;5(5):e20779. doi: 10.2196/20779.

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

Wim van Harten principal investigator

Rijnstate Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Video consultation in people with Obstructive Sleep Apnea, run by Rijnstate Hospital at 1 site in Netherlands.

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 7 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

CPAP use (time frame: Week 1 through week 4). The study lists 2 primary outcomes in all. 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 NCT04563169, which also lists 1 linked publication.

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 24 Sep 2020.