Atopic DermatitisSQUADNCT03490877
Scratch and Sleep Quantification in Atopic Dermatitis
An observational study of Atopic Dermatitis and Pruritus, run by University of Rochester at 1 site in United States.
Trial summary
Atopic dermatitis (AD) is a chronic type of eczema affecting approximately 10% of adults and 12% of children in the US. The intense itching (pruritus) associated with AD can be significantly disruptive to sleep and quality of life for both the patients and their caregivers. AD is challenging to describe and measure. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis, Pruritus, Sleep Disturbance
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 30 Sep 2019
- Phase
- Observational
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female subjects, aged 12-75 years old, with active mild to severe atopic dermatitis (AD)
Who may be able to join
- Male or female subjects aged > 12 to 75 years of age at the screening visit.
- Written informed consent from participant (and parent/guardian for those subjects under 18 years of age) and able to understand and cooperate with study instructions, visits and procedures.
- Native English speakers or fluent in English (per investigator's judgment)
- Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant atopic dermatitis treatments are permitted on study).
- Has AD involvement ≥ 5% Body Surface Area (BSA), excluding the scalp.
- Has an Investigator's Static Global Assessment (ISGA) score of Mild (2), Moderate (3), or Severe (4) at the Screening Visit
- Have a minimum Peak Pruritus Numerical Rating Score (NRS) of 3 and/or Severity of Pruritus Scale (SPS) score of 1.
- Willingness to abstain from alcohol and illicit drugs on the day of the second overnight in-clinic study visit.
Who cannot join
- Has any clinically significant medical disorder, condition, disease or clinically significant physical examination finding at screening that in the Investigator's or designee's opinion may interfere with study objectives (e.g., expose subject to unacceptable risk by study participation, confound evaluation, result in adverse events, or interfere with subject's ability to complete the study).
- Has documented sleep apnea and/or other sleep related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder) or has a Body Mass Index (BMI) >35.
- Subject scores <15 on the Asthma Control Test (ACT; Appendix C), indicating poorly controlled asthma.
- Current shift worker or travel across more than two time zones in the past 2 weeks. (NOTE: for this travel criterion, subjects may enroll in the study if they delay enrollment until two weeks has lapsed since their travel).
- If the patient has significant eczema at the location where the bilateral wrist devices will need to be worn, making the devices intolerable for the patient, and in the opinion of the patient or investigator would likely lead to noncompliance.
- Has a significant active systemic or localized infection, including actively infected AD.
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- If subject has a history of angioedema or anaphylaxis, has not had any anaphylactic reactions within the past 6 months.
- Has recently (within 30 days of the Screening Visit) participated in or is currently involved in another drug or device research study.
- Has any planned surgical or medical procedure that would overlap with study participation.
- Is a female who is breastfeeding or pregnant.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening as disclosed by subject during evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Scratch and Sleep in Atopic Dermatitis
Atopic dermatitis (AD) is a chronic type of eczema affecting approximately 10% of adults and 12% of children in the US. The intense itching (pruritus) associated with AD can be significantly disruptive to sleep and quality of life for both the patients and their caregivers. AD is challenging to describe and measure. The purpose of this study is to see if we can reliably measure how much people with AD scratch and how scratching interferes with sleep and quality of life by using digital sensors, sleep studies and patient-reported information.
Read the detailed description
Wrist worn accelerometers, sleep sensors, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. Our overall aim is to validate the use of accelerometry technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients in a home environment.
Accelerometry devices appear similar to a wristwatch. The subject will be asked to wear an accelerometry device on each wrist during the study. The accelerometry device provides continuous measures of wrist activity and will be used to quantify nocturnal scratching and sleep behaviors to be compared to videography (annotated for scratch), sleep sensor, PSG and traditional patient-reported outcome (PRO) and Quality of Life (QoL) measures [Peak Pruritus Numerical Scale, Severity of Pruritus Scale (SPS), Patient Global Impression of Severity (PGIS), Medical Outcomes Study (MOS) Sleep Scale, Itch and Sleep Diary, Patient-Oriented Eczema Measure (POE), Patient-Reported Outcomes Measurement Information System (PROMIS)-pain interference, PROMIS- anxiety, Dermatology Life Quality Index (DLQI), Family Dermatology Life Quality Index (FDLQI), Children's Dermatology Life Quality Index (CDLQI), Device and Device Comfort Questionnaire] in patients with AD in a clinic and home setting in a well-controlled clinical study.
- Conditions
- Atopic Dermatitis, Pruritus, Sleep Disturbance
- Keywords
- Atopic Dermatitis, Pruritus, Sleep Disturbance
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Parasomnias
What is being measured
The primary outcome is the main question the study is designed to answer.
Scratch Movements
To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.
Measured: 5 days
Sleep Time
To evaluate the agreement between the outcomes of amount of time asleep acquired by polysomnography, sleep sensor pad, and accelerometry.
Measured: 5 days
Secondary outcomes (5)
Sleep Efficiency
To evaluate the agreement between the outcomes of sleep efficiency acquired by polysomnography, sleep sensor pad and accelerometry.
Measured: 5 days
Patient-Reported Outcomes/ Scratch
To evaluate the agreement between the scratch outcomes acquired by accelerometry and patient-reported outcome (PRO) measures (as measured by the scales of the respective PROs).
Measured: 5 days
Patient-Reported Outcomes/ Sleep
To evaluate the agreement between the sleep outcomes acquired by accelerometry and patient-reported outcome (PRO) measures (as measured by the scales of the respective PROs).
Measured: 5 days
Quality of Life/ Scratch
To evaluate the agreement between the scratch outcomes acquired by accelerometry and quality of life measures, as measured by scores of the Quality of Life Questionnaires.
Measured: 5 days
Quality of Life/ Sleep
To evaluate the agreement between the sleep outcomes acquired by accelerometry and quality of life measures, as measured by scores of the Quality of Life Questionnaires.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start13 Jul 2018
- Primary completion30 Apr 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Lisa Beck, University of Rochester
- Investigators
- Lisa A. Beck, MD, Principal investigator, University of RochesterEarl R. Dorsey, MD MBA, Study chair, University of Rochester Medical Center/Center for Health+Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490877
- Sponsor's protocol ID
- SQUAD1.0
- Acronym
- SQUAD
- Status last verified
- Feb 2020
- First submitted
- 20 Mar 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Scratch and Sleep in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03490877
- Acronym / sponsor ID
- SQUAD / SQUAD1.0
- Conditions
- Atopic Dermatitis, Pruritus, Sleep Disturbance
- Keywords
- Atopic Dermatitis, Pruritus, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Apr 2018 (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 (AD) is a chronic type of eczema affecting approximately 10% of adults and 12% of children in the US. The intense itching (pruritus) associated with AD can be significantly disruptive to sleep and quality of life for both the patients and their caregivers. AD is challenging to describe and measure. The purpose of this study is to see if we can reliably measure how much people with AD scratch and how scratching interferes with sleep and quality of life by using digital sensors, sleep studies and patient-reported information.
Detailed description
Wrist worn accelerometers, sleep sensors, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. Our overall aim is to validate the use of accelerometry technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients in a home environment.
Accelerometry devices appear similar to a wristwatch. The subject will be asked to wear an accelerometry device on each wrist during the study. The accelerometry device provides continuous measures of wrist activity and will be used to quantify nocturnal scratching and sleep behaviors to be compared to videography (annotated for scratch), sleep sensor, PSG and traditional patient-reported outcome (PRO) and Quality of Life (QoL) measures [Peak Pruritus Numerical Scale, Severity of Pruritus Scale (SPS), Patient Global Impression of Severity (PGIS), Medical Outcomes Study (MOS) Sleep Scale, Itch and Sleep Diary, Patient-Oriented Eczema Measure (POE), Patient-Reported Outcomes Measurement Information System (PROMIS)-pain interference, PROMIS- anxiety, Dermatology Life Quality Index (DLQI), Family Dermatology Life Quality Index (FDLQI), Children's Dermatology Life Quality Index (CDLQI), Device and Device Comfort Questionnaire] in patients with AD in a clinic and home setting in a well-controlled clinical study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects, aged 12-75 years old, with active mild to severe atopic dermatitis (AD)
Key inclusion criteria (8 listed)
- Male or female subjects aged > 12 to 75 years of age at the screening visit.
- Written informed consent from participant (and parent/guardian for those subjects under 18 years of age) and able to understand and cooperate with study instructions, visits and procedures.
- Native English speakers or fluent in English (per investigator's judgment)
- Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant atopic dermatitis treatments are permitted on study).
- Has AD involvement ≥ 5% Body Surface Area (BSA), excluding the scalp.
Key exclusion criteria (11 listed)
- Has any clinically significant medical disorder, condition, disease or clinically significant physical examination finding at screening that in the Investigator's or designee's opinion may interfere with study objectives (e.g., expose subject to unacceptable risk by study participation, confound evaluation, result in adverse events, or interfere with subject's ability to complete the study).
- Has documented sleep apnea and/or other sleep related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder) or has a Body Mass Index (BMI) >35.
- Subject scores <15 on the Asthma Control Test (ACT; Appendix C), indicating poorly controlled asthma.
- Current shift worker or travel across more than two time zones in the past 2 weeks. (NOTE: for this travel criterion, subjects may enroll in the study if they delay enrollment until two weeks has lapsed since their travel).
- If the patient has significant eczema at the location where the bilateral wrist devices will need to be worn, making the devices intolerable for the patient, and in the opinion of the patient or investigator would likely lead to noncompliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scratch Movements
Time frame: 5 days
To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.
Sleep Time
Time frame: 5 days
To evaluate the agreement between the outcomes of amount of time asleep acquired by polysomnography, sleep sensor pad, and accelerometry.
5 secondary outcomes
Sleep Efficiency
Time frame: 5 days
Patient-Reported Outcomes/ Scratch
Time frame: 5 days
Patient-Reported Outcomes/ Sleep
Time frame: 5 days
Quality of Life/ Scratch
Time frame: 5 days
Quality of Life/ Sleep
Time frame: 5 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 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lisa A. Beck, MD principal investigator
University of Rochester
Earl R. Dorsey, MD MBA study chair
University of Rochester Medical Center/Center for Health+Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Pruritus, run by University of Rochester at 1 site in United States.
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 8 inclusion and 11 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 12 Feb 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 United States. 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?
Scratch Movements (time frame: 5 days). 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?
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 12 Feb 2020.