Influence of Sleep Quality in Patients With Periorbicular Hyperchromia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periorbital Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

About this study

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%.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Pittsburgh Sleep Quality Index

Time frame: at 1 day visit 1

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.

Secondary outcomes

Quality of Life Index in Dermatology

Time frame: at 1 day visit 1

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.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Jan 8, 2018
Registry last updated: Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed