Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

Influence of Sleep Quality in Patients With Periorbicular Hyperchromia: a Case Control Study

Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. POH affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. The most commonly affected people are those with the highest skin phototypes. Although the prevalence is similar between sexes and age groups, POH is a more frequent complaint in women. The dark circles characteristic of POH can negatively impact patients' quality of life, although it is not a condition associated with morbidity. Popularly it is believed that the poor quality of sleep is a factor responsible for its appearance, but there is no consistent data in the literature that prove this.

Study Overview

• Status: Completed
• Conditions: Periorbital Disorder

Detailed Description

We aim to compare the quality of sleep through the Pittsburgh Sleep Quality Index (PSQI-BR) already translated and validated in Portuguese for patients with periorbicular hyperchromia (cases) with patients without this complaint (controls) and to compare dermatological quality of life through the Quality of Life in Dermatology Index (DLQI) already translated and validated for Portuguese patients with periorbicular hyperchromia (cases) with patients without this complaint (controls). Patients and / or family members who consult in the Dermatology of the Hospital de Clínicas of Porto Alegre (preferably), but also other patients and / or relatives with outpatient care in this institution will be invited to participate in the control group.

The WinPepi program, version 11.32, was used to calculate the sample size. This objective predicts a Pareto Control Case study by age, with a ratio of 1: 1. The sample size was 252 subjects, 126 cases and 126 controls. Adding 10% to possible losses and refusals the sample size should be 280 subjects, with 140 cases and 140 controls. This value was stipulated taking into account the mean of 5.9 in the PSQI-BR of the cases already collected (n = 148 subjects) and corresponds to a difference of almost 3 points in the index ranging from zero to 21, corresponding to approximately 15% difference between groups. For this calculation was considered 80% power and significance level of 5%.

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Hospital de Clínicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women over 18 years of age who agree to answer to quality of sleep and quality of life questionnaires. The "case" group should present periorbicular hyperchromia confirmed by physical examination and the group called "control" should not present periorbicular hyperchromia excluded by physical examination.

Description

Inclusion Criteria:

• Cases: Patients with periocular hyperchromia diagnosed by clinical examination.
• Controls: Patients without periocular hyperchromia diagnosed by clinical examination.

Exclusion Criteria:

• Pregnant patients
• Active collagenase patients
• Patients with bacterial or viral infections on the periorbicular area
• Patients undergoing any treatment modality for periocular hyperpigmentation in the last 3 months.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases: patients with dark circles; Patients who believe they have periorbicular hyperchromia and have a confirmatory physical examination performed by a dermatologist.
Controls: patients without dark circles; Patients who believe that they do not have periorbicular hyperchromia under their eyes and have physical examination that excludes dark circles carried out by a dermatologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	To evaluate the sleep quality in patients with periocular hyperpigmentation comparing with patients without periocular hyperpigmentation. The questionnaire consists of 19 questions, which are grouped into 7 components, with values distributed on a scale of zero to 3. These components are subjective quality of sleep, sleep latency, sleep duration, habitual sleep efficiency , sleep disorders, use of sleeping pills, and daytime dysfunction. The scores of these components are summed to form a global score, ranging from zero to 21. The higher the score, the worse the quality of sleep. A PSQI score> 5 indicates that the individual is experiencing major difficulties in at least 2 components, or moderate difficulties in more than 3 components.	at 1 day visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Index in Dermatology	To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life comparing with patients without periocular hyperpigmentation. this is a score used to evaluate the damage caused by dermatological diseases. It consists of 10 questions, with four alternative answers, corresponding to scores from 0 to 3. The maximum score is 30 and the minimum is zero, with 30 being the highest loss in the dermatological quality of life.	at 1 day visit 1

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• Rocha Barone C, Catucci Boza J, Challub Pires G, Perusato Pereira P, Ferreira Cestari T. The influence of sleep quality on the development of periocular hyperchromia: a case-control study. J Cosmet Dermatol. 2020 Jul;19(7):1760-1767. doi: 10.1111/jocd.13195. Epub 2019 Oct 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): February 10, 2020
• Study Completion (ACTUAL): February 10, 2020

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (ACTUAL): January 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Sleep Quality; Dark circles; Periorbital hyperchromia; Facial aesthetics
• Other Study ID Numbers: 150402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No