The Long-term Impact of the Usage of New Generation Massage Chairs on Quality and Quantity of Sleep-in Individuals Suffering from Insomnia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Thessaly
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Sleep Efficiency
Study Overview
Brief Summary
Modern technology is reshaping the massage industry, improving relaxation and well-being with pioneering devices. The automatic massage chairs stand as a testament to this evolution, integrating ergonomic design with advanced massage techniques to facilitate deep tissue relaxation, and sleep quality and enhance overall well-being.
Aim: The aim of the current study is to assess the long-term impact of the new generations of massage chairs prior to bed-time in aspects related to sleep and quality of life in individuals with severe symptoms of insomnia.
Detailed Description
Study Design The current study will assess the impact of daily usage (30 consecutive automatic massage sessions) of deep relaxation full body massage sessions using the 4D new generations' massage chairs in individuals suffering from insomnia. The massage chair will be located in patients' house/bedroom during the whole trial period.
Participants will follow a crossover design with one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-1: one month on, one month off, one month on, and for Group_2: one month off, one month on, one month off. During the "on" period, massage chair is located at participant's house while during the "off" period, massage chair is removed from participant's house.
During the "on" periods, participants could use the massage chair prior to bed time (last action before sleeping) and select from one of twelve programmed relaxation massage options. They were required to use the chair for at least 30 minutes daily, primarily before going to bed. The study was approved by the Human Research and Ethics Committee of the University of Thessaly (2334-5/4-2/7.2.2024). All Subjects gave their written informed consent prior to study participation.
Procedure All measurements will be conducted at the participants' own homes. Massage sessions will be performed in the participants' home prior to bedtime, utilizing the automatic massage chair provided during the study period.
The initial screening requires that all participants score ≥16 on the Athens Insomnia Scale (AIS-8). The Pittsburgh Sleep Quality Index (PSQI) was provided for participants to complete every 30 days over the three-month period. Additionally, during the first visit, all participants completed a series of validated questionnaires assessing quality of life, depression score, sleep quality, stress, and general fatigue. The same questionnaires were also completed during the final visit. After each visit and immediately after the completion of the 30 min automatic massage, participants will be connected to the portable polysomnography system and they will stay alone to follow their bedtime routine. The study recording will be completed when the participant wakes up and disconnects the system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •score of ≥16 on the Athens Insomnia Scale (AIS-8)
Exclusion Criteria
- •history of mental illness,
- •history of epilepsy
- •acute or chronic condition that would limit the ability of the patient to participate in the study
Arms & Interventions
Group 1 - On-Off-On
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-1: one month on, one month off, one month on. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
Intervention: Massage Chair session (Other)
Group 1 - On-Off-On
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-1: one month on, one month off, one month on. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
Intervention: Washout period (Other)
Group 2 - Off-On-Off
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-2: one month off, one month on, one month off. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
Intervention: Massage Chair session (Other)
Group 2 - Off-On-Off
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-2: one month off, one month on, one month off. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
Intervention: Washout period (Other)
Outcomes
Primary Outcomes
Sleep Efficiency
Time Frame: At baseline, after each month and at the end of the 3 months period.
Total sleep time over Time spend in bed
Insomnia Score
Time Frame: At baseline, after each month and at the end of the 3 months period.
For the calculation of the Insomnia score, the Athens Insomnia Scale (AIS-8) will be used. The score ranges from 0 - 24 with a higher number implying worse insomnia symptoms.
Secondary Outcomes
- Sleep Quality Score(At baseline, after each month and at the end of the 3 months period.)
Investigators
Giorgos K. Sakkas
Associate Professor
University of Thessaly