Atopic Dermatitis EczemaACTISLEEPNCT03090178
Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy
A study testing electronic-Patient Report Outcome and wear of a wristband actigraph in people with Atopic Dermatitis Eczema, run by Ad scientiam at 1 site in France.
Trial summary
Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- electronic-Patient Report Outcome and wear of a wristband actigraph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2017to 15 Jun 2018
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients :
- Subjects using a smartphone running Apple operating system (iOS 7 and above) or Android (version 2.2 and above)
- Subjects agreeing to wear the actigraphy wristband at night
- Subjects 18 years old or older
- Subjects affiliated to French Health Insurance
- Subjects treated for moderate to severe atopic dermatitis or atopic dermatitis exacerbation* *The stage of the atopic dermatitis will be assessed by using the Eczema Area and Severity Index (EASI), Body Surface Area (BSA) and Investigator Global Assessment (IGA). The EASI is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis. The EASI was identified as one of the best-validated outcome measures for atopic dermatitis.
Show all 27Show fewer
- A moderate to severe atopic dermatitis corresponds to:
- Eczema Area and Severity Index score ≥ 7.1
- Investigator Global Assessment ≥ 3
- Body Surface Area ≥ 10
- Healthy volunters :
- Subjects using a smartphone running iOS (iOS 7 and above) or Android (version 2.2 and above)
- Subjects agreeing to wear the actigraphy wristband at night
- Subjects 18 years old or older
- Subjects affiliated to French Health Insurance
- Subjects without a dermatology disease
- Non inclusion Criteria:
- -Illiterate subjects
- Subjects not proficient in French
- Subject with a primary insomnia*
- Insomnia, sleep apnea and hypersomnia will be evaluated with respectively 3 tests:
- Insomnia Severity Index (ISI);
- Berlin Sleep Apnea Scale;
- Epworth Scale
- Subjects treated by hypnotic drugs
- Pregnant woman
- Subjects under guardianship
Who cannot join
- If a participant is taking hypnotic treatments during his study participation, he will be excluded from the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on Real-world Data Collection With a Smartphone Application and a Validated Actigraphy Wristband
Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Quality of Life (QoL) can also be evaluated retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data retrospectively introduces a significant recall bias that can be addressed by collecting data in Real World (RW). Real World data collection is prospective and take place within the patient's own environment. While data collection is generally done with diaries, it has been demonstrated that smartphone and connected devices were able to produce more precise and granular data than traditional methods.
Read the detailed description
The main objective of the study is to demonstrate a medical hypothesis using a wristband actigraph: patients with moderate to severe atopic dermatitis have a poorer quality and quantity of sleep than healthy subject.
Secondary objetives are to assess the interest of a smartphone application in evaluating the quality of life of patients with moderate to severe atopic dermatitis in regard of those of healthy volunteers.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- electronic-Patient Report Outcome and wear of a wristband actigraph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic-Patient Report Outcome and wear of a wristband actigraphOther
Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
* sleep diary
* Pruritus
* dermatology life quality index Receives: Other: electronic-Patient Report Outcome and wear of a wristband actigraph |
| Healthy Volunteers | Active comparator | Wear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
* sleep diary
* Pruritus
* dermatology life quality index Receives: Other: electronic-Patient Report Outcome and wear of a wristband actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Measure of sleep quality
Measured: 15 days
Secondary outcomes (1)
Sleep quantity
Measure of sleep quantity
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start2 Jun 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Investigators will first enroll patients, then healthy volunters. Healthy volunters will be matched to patients on age, sexe and wake up at a programmed time
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090178
- Sponsor's protocol ID
- P004
- Acronym
- ACTISLEEP
- Status last verified
- Aug 2018
- First submitted
- 20 Mar 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on Real-world Data Collection With a Smartphone Application and a Validated Actigraphy Wristband
- ClinicalTrials.gov ID
- NCT03090178
- Acronym / sponsor ID
- ACTISLEEP / P004
- Conditions
- Atopic Dermatitis Eczema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 24 Mar 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.
Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Quality of Life (QoL) can also be evaluated retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data retrospectively introduces a significant recall bias that can be addressed by collecting data in Real World (RW). Real World data collection is prospective and take place within the patient's own environment. While data collection is generally done with diaries, it has been demonstrated that smartphone and connected devices were able to produce more precise and granular data than traditional methods.
Detailed description
The main objective of the study is to demonstrate a medical hypothesis using a wristband actigraph: patients with moderate to severe atopic dermatitis have a poorer quality and quantity of sleep than healthy subject.
Secondary objetives are to assess the interest of a smartphone application in evaluating the quality of life of patients with moderate to severe atopic dermatitis in regard of those of healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will first enroll patients, then healthy volunters. Healthy volunters will be matched to patients on age, sexe and wake up at a programmed time
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: electronic-Patient Report Outcome and wear of a wristband actigraphWear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application: * sleep diary * Pruritus * dermatology life quality index |
| Healthy Volunteers | Active comparator | Other: electronic-Patient Report Outcome and wear of a wristband actigraphWear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application: * sleep diary * Pruritus * dermatology life quality index |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subjects using a smartphone running Apple operating system (iOS 7 and above) or Android (version 2.2 and above)
- Subjects agreeing to wear the actigraphy wristband at night
- Subjects 18 years old or older
- Subjects affiliated to French Health Insurance
- Subjects treated for moderate to severe atopic dermatitis or atopic dermatitis exacerbation* *The stage of the atopic dermatitis will be assessed by using the Eczema Area and Severity Index (EASI), Body Surface Area (BSA) and Investigator Global Assessment (IGA). The EASI is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis. The EASI was identified as one of the best-validated outcome measures for atopic dermatitis.
Key exclusion criteria (1 listed)
- If a participant is taking hypnotic treatments during his study participation, he will be excluded from the clinical trial.
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 |
|---|---|---|
| electronic-Patient Report Outcome and wear of a wristband actigraphMeasurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome | Other | Healthy Volunteers, Patients |
Primary outcome
Sleep quality
Time frame: 15 days
Measure of sleep quality
1 secondary outcome
Sleep quantity
Time frame: 15 days
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 8 Aug 2018.
Related trials for Atopic Dermatitis Eczema
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic-Patient Report Outcome and wear of a wristband actigraph in people with Atopic Dermatitis Eczema, run by Ad scientiam at 1 site in France.
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 27 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 8 Aug 2018. 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 France. 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?
Sleep quality (time frame: 15 days). 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 8 Aug 2018.