Anti age cushion OMNIA.

Prospective analysis of the improvement in the appearance of sleep wrinkles after the use of a specific anti-wrinkle pillow for 12 weeks.

Sara Gómez-Armayones, PhD,¹² Lorena Barboza Guadagnini, MD,¹² Noelia Martínez-Martínez, MD,¹ Dídac Barco Nebreda, MD¹

¹ Corium Dermatology Barcelona, Spain

² Department of Dermatology, Hospital Clínic of Barcelona, Spain

ETHICAL STATEMENT

All participants provided written informed consent prior to inclusion in the study. This article contains photographic images used for scientific and educational purposes in the context of cosmetic dermatology. Written informed consent was obtained from all individuals whose images are included in this manuscript.

ACKNOWLEDGMENTS

The authors thank Dr. Inés Escandell González for valuable ideas in the preparation of this article.

AUTHORS’ CONTRIBUTIONS

Sara Gómez-Armayones developed the protocol, coordinated the study as principal investigator, and analyzed the data. All authors enrolled patients in the study and participated in manuscript development and review.

CONFLICT OF INTEREST STATEMENT

The authors have no conflicts of interest to declare.

DECLARATION OF DATA AVAILABILITY

Data supporting the findings of this study are available on request from the responsible author.

Background

To demonstrate a reduction in the diameter and roughness of sleep wrinkles through the use of the OMNIA ergonomic pillow.

A 12-week observational study was conducted in which 23 healthy volunteers, women between the ages of 37 and 61, were evaluated for a total of 28 wrinkle lines using LiveViz® Micro QuantifiCare visual assessment at baseline and after 12 weeks of pillow sleep. The degree of wrinkle improvement from pillow sleep was assessed by measuring wrinkle diameter and roughness parameters using LiveViz® Micro QuantifiCare. In addition, the clinical and roughness images produced by the program were evaluated by three expert dermatologists

Use of the pillow resulted in a significant reduction in sleep wrinkles after 12 weeks. Based on 3D measurements, a global decrease in wrinkle diameter of 29.4% (P<0.001) and a decrease in the roughness parameter Rv of 15.8% (P<0.009) were observed. These parameters showed improvement across all age groups, for wrinkles classified in groups II and III according to the Glogau scale and for all wrinkle locations. As assessed by three expert dermatologists, 82.1% of sleep wrinkles showed some degree of improvement. No adverse reactions were recorded during the duration of the study.

Sleeping on a specific ergonomic pillow leads to a reduction in the diameter of sleep wrinkles and skin roughness.

KEYWORDS

Pillow, sleep wrinkles, roughness, Glogau scale

Sleep wrinkles (VS), also known as sleep creases, were first described as “sleep crashes” by Stegman in 1987. As the name suggests, these wrinkles are related to skin pressure against the pillow, with the lateral sleep position being the most common.¹ ² These lines, which are not primarily caused by facial muscle movements, are distinct from the wrinkles that map aging and facial expressions. Clinically, VS typically manifest as oblique to vertical lines across the forehead, in the area around the orbicularis oculi muscle, or on the lateral surfaces of the nose and chin, associated with the superficial musculo-aponeurotic system.³ ⁴ The formation of VS has been attributed to deformation of the face under pressure, shear, and stress while lying on the side or on the stomach,³ leading to lines that are initially inconspicuous but may become more pronounced with persistent sleep in the same position. Since these lines visibly reflect the stress exerted on the facial skin, they can be easily mimicked by imitating the same pressure with the hand.³

Furthermore, the formation of these wrinkles may be particularly associated with the natural aging process, which is influenced by a combination of intrinsic (chronological age, gender, hormonal status) and extrinsic aging factors (sun exposure, smoking, environmental factors). Stiffening of the stratum corneum and dermis, as well as changes in collagen, elastin fibers, proteoglycans, and water content are consistent features of this process. These changes reduce the elasticity and extensibility of the skin, in addition to reducing its regenerative capacity and physiological hydration levels.³

Sleep positioning patterns change with age. The number of position changes during the night tends to decrease with age, from an average of 27 to 16 position changes per night, with an overall average of 20 position changes per night. In addition, side sleep position is the most common sleep position, with an average of 65% of sleep time. It is unusual to spend the entire sleep period in one position.³ ⁵

The most reliable way to reduce the development of sleep-related wrinkles is to avoid facial distortion during sleep. This can be achieved by sleeping on your back, as this position typically reduces the amount of pressure on the face and skin. However, sleeping in this position can exacerbate breathing-related problems such as snoring and sleep apnea. Some individuals may find it uncomfortable or challenging to maintain a simple sleep position throughout the night, and it may not be an appropriate solution for all patients.³ another strategy to reduce or prevent the development of VS and ensure good quality rest is the use of specially designed pillows aimed at relieving the classic pressure points on the face associated with VS formation.³ ⁵ ⁶

Twenty-four women were enrolled based on inclusion and exclusion criteria

Each participant received detailed information about the purpose of the study, the protocol, the timeline, the benefits and the potential risks. Those willing to participate signed an informed consent form and received an Omnia Sleep&Glow pillow (see Figure 1) made of polyurethane memory foam (dimensions: 34 x 54 x 13 cm; weight: 1.08 kg) and a pillowcase consisting of Tencel (natural eucalyptus fibers) and a base layer consisting of 90% polyester and 10% spandex. Participants were instructed to wash the sheets according to their normal washing and drying procedures.

Figure 1. Features of the Omnia Sleep&Glow pillow.

Before and after a 12-week period of consistent pillow use, sleep wrinkles (VS) were assessed by capturing images using a 3D imaging system (LiveViz® Micro QuantifiCare). All images were captured in a controlled environment, in the same room, under identical light and temperature conditions (23°C +/- 1), and skin cleansing was performed prior to image capture. The mean VS was measured based on clinical and roughness images provided by the QuantifiCare software. Three expert dermatologists performed a visual assessment of clinical improvement, categorizing the results into three levels: significant improvement, mild or moderate improvement, and no improvement or worsening of VS.

Wrinkle imaging was performed using the QuantifiCare® LiveViz Micro™, a compact and portable 3D system adapted to the Nikon D5600 camera (Figure 2). This device includes integrated dual light indicators to ensure improved image reproducibility. The images were visualized using DermaPix® software and VS roughness parameters (Rv, Rmax, Ra, Rz; Table 2) were analyzed using the 3D Analysis™ module, which allows the assessment of minimal changes on the skin surface, reaching resolutions up to 8 μm, and also allows volumetric measurements by analyzing structural changes in colorimetric and topographic features.

Figure 2. Quantificare® LiveViz Micro™

Among the 24 volunteers initially enrolled, 23 completed the study; one participant discontinued participation due to inability to adjust to the cushion. Five patients were evaluated for two wrinkles, resulting in an analysis of a total of 28 VSs in different localizations (forehead, cheek, paranasal, periocular, and supralabials). All patients were evaluated by expert dermatologists who determined the origin of the wrinkle through direct clinical evaluation and the pillow test,⁴ which involves evaluating the suspicious wrinkle by applying pressure with the hand or pillow to highlight the wrinkle and differentiate it from expression lines. Wrinkles that disappeared several hours after overnight rest were excluded. All volunteers used the pillow continuously for 12 weeks.

The age range of the volunteers who completed the study was between 37 and 61 years, with a mean age of 50.8 years (SD=8) (see Table 3). All volunteers were assessed and categorized according to the Glogau scale: I (mild), II (moderate), III (advanced), IV (severe). Slightly more than half of the study participants (18 patients, 57.1%) belonged to group III. The location of the wrinkles was predominantly on the cheeks in almost half of the patients (12 patients, 42.9%). In 8 patients (28.6%) the wrinkles were localized on the forehead and similarly in 8 patients (28. 6% ) the wrinkles were in the paranasal, periocular or supralabials areas.

Table 3. Description of the volunteers’ characteristics

SD: Standard deviation

¹ Right anterior (3), Left anterior (5), Right zygomatic (6), Left zygomatic (6), Right paranasal (2); Left paranasal (1), Right periocular (2), Left periocular (1), Right supralabials (), Left supralabials (2).

² Paranasal or Periocular or Supralabials.

After using the cushion, the average wrinkle diameter decreased from 27.92 mm to 19.70 mm. The 29.4% reduction was statistically significant (p-value < 0.001). The mean Rv before intervention was 0.19 mm, which decreased to 0.16 mm after the use of the cushion. This 15.8% reduction was also statistically significant (p-value = 0.009) (Table 4).

Statistically significant reduction in wrinkle diameter was observed in both age groups. In patients younger than 50 years of age, the reduction was 30.4%, while in patients aged 50 years and older, the reduction was 27.9%. In addition, patients younger than 50 years showed statistically significant reductions in Rv, Rmax, and Rz (Rv: p-value < 0.021; Rmax: p-value = 0.039; Rz: p-value = 0.049), as shown in Table S1.

The table shows the mean (standard deviation).

¹ Student’s t-test for paired data

* Statistically significant difference when comparing before and after cushion use (p-value < 0.05).

† A decrease (↓) in the mean value represents an improvement in skin wrinkles.

Regarding the classification according to the Glogau scale, a statistically significant decrease in parameters was observed in all groups. Specifically, in patients classified as Glogau II, there was a 36.8% reduction in the mean sleep wrinkle diameter. In patients classified as Glogau III, there was a 28.8% reduction, and in patients classified as Glogau IV, there was a 25.2% reduction. Rv, Rmax, and Rz also demonstrated an improvement in sleep wrinkles for Glogau scale scores II or III (Rv II: p-value = 0.05; Rv III: p-value = 0.011; Rmax II: p-value = 0.002; Rmax III: p-value = 0.024; Rz II: p-value = 0.002; Rz III: p-value = 0.029), but not for patients with Glogau IV scores (Table S2).

Regarding the localization of sleep wrinkles, the reduction was 35.4% in patients with forehead wrinkles, whereas it was 25.2% in patients with cheek wrinkles and 30.8% in patients with wrinkles at other sites (paranasal, periocular, and supralabials). Rv showed a statistically significant improvement in wrinkles located in the paranasal, periocular and supralabials sites (p-value = 0.001). Rmax and Rz showed a statistically significant decrease in patients with wrinkles on the forehead and other various sites (forehead Rmax: p-value = 0.013; other sites Rmax: p-value = 0.001; forehead Rz: p-value = 0.018; other sites Rz: p-value = 0.001) (Table S3).

The improvement of the mean and Rv for the study variables (age, Glogau scale score, and wrinkle location) is shown in Figures 3 and 4. Figure 5 and Figure 6 show patient 10 (right cheek) and patient 15 (left forehead) through 3D clinical images, overall wrinkle area roughness, and specific wrinkle roughness at W0 and W12. All cases are shown in Supplementary Material S2.

As assessed by three expert dermatologists, 39.3% of the wrinkles evaluated showed significant improvement, 42.8% showed moderate to slight improvement, and 17.9% did not improve or worsened. Based on this assessment, 82.1% of the wrinkles evaluated showed some degree of improvement. No adverse reactions were noted during the study.

Figure 5. Clinical picture, roughness pattern, and average roughness and wrinkles in patient 10 at baseline (W0) and after 12 weeks (W12) (location: right cheek).

DISCUSSION

Improving VS using ergonomic cushions has been suggested in some publications. The only reliable way to minimize VS is to avoid facial deformity, and the use of cushions specifically designed for this purpose appears to be a promising alternative.⁶ ⁷ To our knowledge, this is the largest study investigating the effect of these cushions.

Patients were evaluated by expert dermatologists who determined the origin of the wrinkle through clinical evaluation and pillow test. This analysis confirmed that the wrinkle is not an expression line and remains unchanged when the facial muscles are relaxed. Participants required between 2 and 6 weeks to adapt to continuous nightly pillow use; a similar adaptation period to that previously reported in the literature.⁴

Analysis of mean and roughness parameters, performed using high precision equipment, revealed significant improvement in VS following the use of the special pillows for 12 weeks. This period coincides with the estimated time frame for improvement of these wrinkles as suggested by Steagman, the first author to describe these wrinkles and their probable association with night rest.¹ The mean average VS decreased by 29.4%, while the reduction in the Rv parameter was 15.8% during this period, both results being statistically significant. A decrease in mean value was also observed in all age groups, with a more pronounced decrease in patients younger than 50 years. With age, the skin loses elasticity and stiffens, leading to the development of deeper wrinkles that become permanent over time. These results could be attributed to the greater elasticity of the skin and the lower photoaging characteristics of younger skin, which may provide an increased ability or rate of skin regeneration once the mechanical stress that conventional cushions can exert on the skin is removed. These results demonstrate the utility of the pillows in both younger and older patients with established wrinkles.

On the other hand, more significant wrinkle improvement was observed with lower scores on the Glogau scale, suggesting that the use of these pillows may yield better results in patients with less chronic and photoaging. The most frequent location of the wrinkles analyzed was on the cheeks (50% on the right cheek and 50% on the left cheek). The literature reports a population preference for sleeping on the right side,⁸ ⁹ which is not consistent with our results, as our study found 46% of wrinkles on the right facial area and 54% on the left facial area. Significant improvement in VS was observed in all locations, with the most significant improvement observed in the frontal region, for both diameter and roughness parameters, both of which were statistically significant.

There are treatments that can temporarily improve the appearance of these wrinkles, such as injection of dermal fillers. However, their effect is temporary and may lead to significant adverse effects, especially in certain locations.¹⁰ The use of these ergonomic pillows appears to be a simpler, safer, and more cost-effective method of specific treatment for VS compared with these therapies, and we consider it a useful therapeutic strategy to prevent the progression of external aging.

A clinical evaluation performed by three expert dermatologists revealed some degree of wrinkle improvement in 82% of cases, with very significant improvement observed in 39.3% of the VS evaluated.

One limitation of the study is the potential artifacts generated by

by Quantificare® LiveViz Micro™. To address this issue, multiple photographs were taken, allowing a large dataset for comparative analysis at W0 and W12.

The findings of the study lead us to the theory that long-term use of an ergonomic cushion could improve or even eliminate these wrinkles, depending on the age and skin characteristics of the patient, but long-term studies are needed to assess the change in these VS, their preventive role, and their potential for reversal depending on their location.