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AzTrials

Sleep QualityRoboSleepNCT06784700

The Usefulness of Automatic Massage Chairs Before Bedtime in Sleep Quality.

A study testing Massage in people with Sleep Quality and Relaxation, run by University of Thessaly at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Modern technology is transforming the field of massage, enhancing relaxation and wellness through innovative devices. The automatic electric massage chair exemplifies this advancement, merging ergonomic design with advanced massage techniques to promote deep tissue relaxation and an overall sense of well-being. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Quality, Relaxation
What is being tested?
Massage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteGreece
Study dates
4 Mar 2024to 13 Dec 2024
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ability to consent

Who cannot join

  • history of mental illness,
  • sleep disorders,
  • history of epilepsy,
  • an acute or chronic condition that would limit the ability of the patient to participate in the study.

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • School of Physical Education, Sports and Dietetics, TEFAA

    Trikala, Thessaly, 42100

Other trials in Greece

About this study

Official title: New Generation Automatic Massage Chairs: Testing Various Massage Protocols for Promoting Relaxation and Favoring Sleep Efficiency in Healthy Individuals

Modern technology is transforming the field of massage, enhancing relaxation and wellness through innovative devices. The automatic electric massage chair exemplifies this advancement, merging ergonomic design with advanced massage techniques to promote deep tissue relaxation and an overall sense of well-being. The purpose of the present study is to examine the effectiveness of various automatic massage protocols available in massage chairs on relaxation and indices of sleep quality in healthy individuals before daytime naps.

Read the detailed description

Study Design Subjects will be randomly assigned into 4 conditions, each one week apart. More particular; 1) In the control condition (CON), where subjects will not receive any massage program; instead, they will be rested for 30 min on an automatic switch-off electric massage chair and subsequently lay down for an additional 30 min on a proper double-bed; 2) In the "Easy Sleep" condition (ES), where subjects will receive a preselected massage program for 30 minutes, followed by an additional 30 minutes of lying down on the same double bed; 3) In the "Fatigue Revover" condition (FR), where subjects will receive a pre selected massage program for 30 minutes, followed by an additional 30 minutes of lying down on the same double bed; 4) In the "Worker Mode" condition (WM), where subjects will receive a preselected massage program for 30 minutes, followed by an additional 30 minutes of lying down on the same double bed. All conditions will be conducted one week apart, at the same time of the day, and the order of the various conditions will be randomly assigned. The researchers analyzing the data will be blinded to the designated groups. The study is approved by the Human Research and Ethics Committee of the University of Thessaly (2334-4/4-2/7.2.2024). All subjects will give their written informed consent prior to study participation.

Data Analysis The data collection period is structured into a single phase, lasting 60min (30min massage chair + 30min nap time).

Procedure All measurements will be performed in the Lifestyle Medicine Laboratory, at the Department of Physical Education and Sports Science of Trikala, in Thessaly, Greece.

Before the initiation of the study, participants will complete a visual analog Sleepiness Scale (VASS), measurements related to overall health and they will be connected to the portable EEG/EOG polysomnography system (HST-mit-tablet, Somomedics, Germany).

Participants will be positioned inside the automatic massage chair for 30 min and moved to a double bed for 30 more minutes after the completion of the pre-selected massage session. The VASS will be used after the massage session and after the 30-minute "nap time" on the double bed.

Additionally, at the start and the end of each condition, participants will perform three maximum handgrip attempts to assess muscle tone, as well as measurements of vital signs, such as heart rate and blood pressure. The study will be considered finalized when the participant completes 1 hour of recording.

Body Composition Body composition will be assessed using anthropometric measurements, including BMI and bioelectrical impedance analysis with a Tanita DC-360S device (Tanita Corporation, Tokyo, Japan), following standard methodology.

Sleepiness Scale (VASS) The visual analog sleepiness scale is used to assess levels of sleepiness among participants, employing a 1-10 rating system as usual. Specifically, the levels of the scale are reported as follows: 0-2 indicated "no sleepiness", 3-5 indicated "moderate sleepiness", 6-8 indicated "high sleepiness" and 9-10 indicated "very high sleepiness".

Sleep Assessment A portable sleep monitoring system will be used to assess sleep quality and quantity (Home Sleep Test, Somnomedics, GmbH, Germany). The system records EEG, EOG, and EMG signals overnight. EEG data will be analyzed in 30-second epochs using SomnoMed-ics PSG analysis software (Domino panel ver. 3.0.0.8) with manual editing. The HomeSleepTest REM+ device will be used for PSG, with electrodes to be placed according to the 10/20 system on key brain regions: Fp1 (left) and M1 for EEG, and near the eyes for EOG. This setup ensures accurate monitoring of sleep architecture and high-fidelity recordings of brain activity and eye movements.

Analysis of the sleep study will be reported as follows: Total Sleep Time (total amount of sleep time scored during the total recording time); Sleep Efficiency (Total sleep time/Time in bed); Sustained Sleep Efficiency (Total sleep time/(Time in bed - Sleep laten-cy stage 2); Sleep Latency (the period of time it takes for a person to fall asleep after they have gone to bed and tried to initiate sleep); Sleep Latency N1 (the period of time between wakefulness and when sleep begins); Sleep Latency N2 (the period of time between time in bed and sleep onset stage 2); REM Latency (the amount of time elapsed between the onset of sleep to the first REM stage).

Handgrip strength assessment The handgrip test is used for the assessment of maximum isometric strength of the hand and arm muscles (Marsden MG-4800 Hand Dynamometer) and will be used as a measurement of muscle tone alertness. Reduction of muscle strength after the intervention will be consindered as reduction of muscle tone.

Massage Session Automatic Electric Massage Chair (AEMC) The Z1 Full Body 4D Massage Chair (Z1-SL Massage Chair, China, www.back2life.gr) will be used in the current study. The Z1-SL chair features a curved rail mechanism for both S-shaped (horizontal) and L-shaped (vertical) massages, covering areas from the head down toes. It includes 58 air cushions for air compression massage, while intelligent mechanical arms, rotating 360°, follow the body's contour, scanning and targeting specific areas for treatment.

The chair integrates a 4D massage system with professional techniques such as kneading, tapping, shiatsu, stretching, air compression, roller, and thermal massage. These techniques allow multidimensional effects in width, length, and depth, tailored to individual needs. Twelve automated programs vary in intensity, and the roller mechanism adjusts to body widths of 3 to 22 cm for focused application to areas like the cervical spine, back, and lower back.

The chair's infrared preheating function (carbon fiber-based) enhances relaxation and circulation by heating the back, pelvis, and thighs. This feature, combined with an extendable foot section and an airbag/roller system, ensures comfort for individuals of different sizes, providing muscle relaxation, fatigue relief, and improved blood circulation.

Massage Auto-Programs of the AEMC According to the massage chair manufacturer, the three preselected automatic massage programs are designed to promote relaxation, alleviate muscle tension, and support recovery by targeting specific muscle groups through various massage techniques.

Easy Sleep The Easy Sleep (ES) program is designed to induce full-body relaxation through gentle, slow movements and mild air compression, making it ideal for pre-sleep use. The automatic session lasts a total of 30 minutes, targeting specific body areas and divided into upper and lower sections. The techniques include kneading, tapping, rolling and deep tissue massage, focused on the following muscle groups.

Upper Body:

  1. Cervical Spine and Shoulders: Circular motions and moderate-intensity tapping are applied to the cervical spine and shoulders (Duration: 22 minutes). ii. Back and Arms: Circular motions and deep tissue massage are applied to the muscles of the back and forearms, including both anterior and posterior surfaces (Duration: 18 minutes). iii. Spinal Area: Circular movements and moderate-intensity tapping are applied along the spine (Duration: 8 minutes).

Lower Body:

iv. Gluteal Muscles and Biceps Femoris: Circular movements combined with medium-pressure deep tissue techniques target the gluteal and biceps femoris muscles (Duration: 6 minutes).

  1. Gastrocnemius (Calf): Circular motions and deep tissue massage techniques are applied to the calf muscles (Duration: 17 minutes). vi. Achilles Tendon and Feet: Rolling motions target the foot area, with moderate intensity pulling on the Achilles tendon (Duration: 20 minutes).

Fatigue Recovery The Fatigue Recovery (FR) program is designed to relax muscles and relieve fatigue after an intense day, enhancing blood circulation and promoting muscle recovery. The automatic session lasts a total of 30 minutes, targeting specific body areas divided into upper and lower sections. Techniques include kneading, tapping, rolling and deep tissue massage, applied to the following muscle groups.

Upper Body:

  1. Cervical Spine and Shoulders Circular motions and moderate-intensity tapping are applied to the cervical spine, with medium-pressure deep tissue techniques focused on the shoulder region (Duration: 13 minutes). ii. Back and Arms: Circular motions and moderate-intensity tapping are used across all muscle zones of the back, while deep tissue massage focuses on the forearm muscles, including both anterior and posterior surfaces (Duration: 13 minutes). iii. Spinal Area: Circular movements and moderate-intensity tapping are applied along the spine (Duration: 11 minutes).

Lower Body:

iv. Gluteal Muscles and Biceps Femoris: Circular movements combined with medium-pressure deep tissue techniques target these muscles (Duration: 7 minutes).

  1. Gastrocnemius (Calf): Circular motions and medium-pressure deep tissue massage techniques are applied to the calf muscles (Duration: 16 minutes). vi. Achilles Tendon and Feet: Rolling motions target the foot area, with moderate-intensity pulling on the Achilles tendon (Duration: 18 minutes).

Worker-mode The Workermode (WM) program is designed for individuals who spend extended hours sitting or engaged in intense work. It alleviates tension in the shoulders, back, and lower back. This automatic 30-minute session targets specific areas, divided into upper and lower body sections, using techniques like kneading, tapping, rolling and deep tissue massage, applied to the following muscle groups.

Upper Body:

  1. Cervical Spine and Shoulders: Circular motions and moderate-intensity tapping are applied to the cervical spine, with medium-pressure deep tissue techniques focused on the shoulder region (Duration: 14 minutes). ii. Back and Arms: Circular motions and moderate-intensity tapping are used across all muscle zones of the back, with deep tissue massage targeting the forearm muscles, including both anterior and posterior surfaces (Duration: 21 minutes). iii. Spinal Area: Circular movements and moderate-intensity tapping are applied along the spine (Duration: 10 minutes).

Lower Body:

iv. Gluteal Muscles and Biceps Femoris: Circular movements combined with medium-pressure deep tissue techniques target these muscles (Duration: 11 minutes).

  1. Gastrocnemius (Calf): Circular motions and medium-pressure deep tissue massage techniques are applied to the calf muscles (Duration: 18 minutes). vi. Achilles Tendon and Feet: Rolling motions target the foot area, with moderate-intensity pulling on the Achilles tendon (Duration: 17 minutes).

Statistical Analysis The statistical analysis will be performed using IBM SPSS Statistics version 29 (SPSS Inc., Chicago, U.S.A.) An independent samples T-test will be used to assess significant differences in basic characteristics between male and female participants. A General Linear Model (GLM) Repeated Measures ANOVA will be used to compare within subject's differences between the 4 conditions (CON-ES-FR-WM). Moreover, a General Linear Model (GLM) Repeated Measures ANOVA will be used to assess changes in EEG parameters among the 4 different conditions. A Bonferroni post-hoc test will be performed to assess individual differences. To assess normality, the Shapiro-Wilk test will be used alongside graphical representations, including the Normal Q-Q plot, Detrended Normal Q-Q plot, and Box Plot. The significance level set at 5%. Beyond significance testing (p-value), effect size is also considered to evaluate the magnitude of the effect.

Power Analysis Sample size calculations were conducted using G*Power 3.1. The a priori "GLM": Repeated measures, within factors" method was used to calculate the power analysis. The power analysis revealed that with a sample size of 12 participants, the study achieved 99% power using sleep efficiency as a primary outcome [(Effect size= 1.5609, Critical F= 2.8915, Ndf 3, Ddf 33, Power (1-β err pob) = 0.9999 (99% power)].

Being tested
Massage, No intervention
Keywords
insomnia, massage, massage chair, sleep efficiency, wellness
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MassageOther

    Participants will be positioned inside a massage chair for a 30-min, followed by an additional 30-minute period of lying down on a proper double bed.

  • No interventionOther

    Subjects will not receive any massage program; instead, they will be rested for 30 minutes on an automatic switch-off electric massage chair and subsequently lay down for an additional 30 minutes on a proper double bed;

Study groups in NCT06784700
Study groupRoleWhat they receive
ControlSham comparatorThe Control (CON) condition involves a 30-minute rest on a switch-off massage chair (without running any massage session).
Receives: Other: No intervention
Easy-SleepExperimentalThe Easy Sleep (ES) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to promote sleep.
Receives: Other: Massage
Fatigue-RecoveryExperimentalThe Fatigue Recovery (FR) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to reduce muscle fatigue.
Receives: Other: Massage
Worker-ModeExperimentalThe Worker Mode (WM) automatic massage condition involves a 30-minute inside the massage chair receiving a relaxation massage designed to promote muscle relaxation.
Receives: Other: Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep Efficiency

    Total sleep time over Time spend in bed.

    Measured: 60 minutes - at the end of the intervention

Secondary outcomes (1)
  1. Sleepiness

    The visual analog sleepiness scale will be used to assess levels of sleepiness among participants, employing a 1-10 rating system as usual. Specifically, the levels of the scale is: 0-2 indicated "no sleepiness", 3-5 indicated "moderate sleepiness", 6-8 indicated "high sleepiness" and 9-10 indicated "very high sleepiness".

    Measured: At baseline and at the end of the intervention (60 minutes).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start4 Mar 2024
  3. Primary completion23 Aug 2024
  4. Study completion13 Dec 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784700
Sponsor's protocol ID
2334-4/4-2/7.2.2024
Acronym
RoboSleep
Status last verified
Jan 2025
First submitted
14 Jan 2025
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Fu M, Sun C, Liu T, Li S. EFFECT OF MASSOTHERAPY ON THE FATIGUE RECOVERY USING THE SMART MASSAGE CHAIR: A RANDOMIZED CONTROLLED TRIAL. J Mech Med Biol. 2022;22(9). doi:10.1142/S0219519422400462

  • Kim YJ, Kim HR, Jung YH, Park YH, Seo SW. Effects of Electrical Automatic Massage on Cognition and Sleep Quality in Alzheimer's Disease Spectrum Patients: A Randomized Controlled Trial. Yonsei Med J. 2021 Aug;62(8):717-725. doi: 10.3349/ymj.2021.62.8.717.

    PubMed 34296549
  • Ntoumas I, Antoniou N, Giannaki CD, Papanikolaou F, Pappas A, Dardiotis E, Karatzaferi C, Sakkas GK. New Generation Automatic Massage Chairs for Enhancing Daytime Naps: A Crossover Placebo-Controlled Trial. Healthcare (Basel). 2025 Sep 12;13(18):2291. doi: 10.3390/healthcare13182291.

    PubMed 41008423

Questions about this trial

What is this clinical trial studying?

A study testing Massage in people with Sleep Quality and Relaxation, run by University of Thessaly at 1 site in Greece.

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 1 inclusion and 4 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 23 Jan 2025. 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 Greece. 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. Some participants in this study may receive a placebo. 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 Efficiency (time frame: 60 minutes - at the end of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784700, which also lists 3 linked publications.

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 23 Jan 2025.

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