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The effect of breathing relaxation to improve poor sleep quality in adults using a huggable human-shaped device: a randomized controlled trial

  • Psychiatrics • Original Article
  • Published:
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Abstract

Purpose

To examine whether or not breathing relaxation, using a huggable human-shaped device, improves poor sleep quality in adults.

Methods

We conducted a randomized controlled trial using outpatients with sleep problems from two clinics in Japan. The intervention group conducted three minutes of breathing relaxation using a huggable human-shaped device before going to bed every night for four weeks. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), at pre-intervention, mid-intervention (2 weeks after pre-intervention), and post-intervention (4 weeks after pre-intervention). We employed intention-to-treat analysis.

Results

A total of 68 participants (mean [SD] age, 41.7 [11.4] years; 64 female [95%]) were randomly assigned to the intervention group (n = 29, mean [SD] age, 43.6 [9.5] years; 28 female [97%]) and the control group (n = 36, mean [SD] age, 40.3 [12.7] years; 36 female [95%]). The intervention group showed a significant decrease in the PSQI score compared to the control group (F = 3.81, p = 0.025, effect size (η2) = 0.057). Furthermore, we found the intervention to be more effective in participants without suicide risk and with a lower number of adverse childhood experiences (effect size (η2) = 0.080 and 0.160, respectively).

Conclusions

A novel psychological intervention, breathing relaxation using a huggable human-shaped device, may be effective to improve sleep quality among people with sleep problems, especially those without severe psychological symptoms.

Trial Registration: UMIN000045262. (Registration Date: September 28th, 2021).

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Data Availability

The datasets generated during and analyzed during the current study are not publicly available due to ethical restrictions but are available from the corresponding author upon reasonable request.

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Acknowledgements

We are grateful to Dr. Yoshihiro Ito at Cocokara Heart Clinic for providing the study field, the staff members of Cocokara Womens’s Clinic and Cocokara Heart Clinic for conducting the survey, and Ms. Hanayo Matsukura at Tokyo Medical and Dental University for supporting the recruit of the participants. We would like to thank all patients who participated our study.

Funding

This work was supported by JSPS KAKENHI (21K18294) and Japan Science and Technology CREST (JPMJCR18A1).

Author information

Authors and Affiliations

  1. Department of Health Policy, Tokyo Medical and Dental University (TMDU), Tokyo, Japan

    Satomi Kato Doi & Aya Isumi

  2. Department of Global Health Promotion, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan

    Yui Yamaoka, Juri Yamazaki & Takeo Fujiwara

  3. Department of Psychiatry and Behavioral Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan

    Shiori Shakagori

  4. Cocokara Women’s Clinic, Aichi, Japan

    Kanako Ito

  5. Advanced Telecommunications Research Institute International, Kyoto, Japan

    Masahiro Shiomi & Hidenobu Sumioka

Authors
  1. Satomi Kato Doi
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Contributions

TF, SD, AI, IK designed the study and managed the administration of the study, including the ethical review process. SD, AI, YY, SN, and JY collected and managed the data of the study. SD, YY, and SN analyzed data. SD drafted the manuscript. TF and MS obtained funding. HS and MS provided material support. TF and HS provided critical comments on the manuscript related to the intellectual content. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Takeo Fujiwara.

Ethics declarations

Ethical approval

All procedures performed in studies involving human participants were following the ethical standards of the Ethics Committee of the Tokyo Medical and Dental University (M2016-284–05) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The trial is registered at UMIN Clinical Trial Registry (Number: UMIN000045262).

Informed consent

Informed consent was obtained from all individual participants included in the study.

Competing interest

Devices (Hugvie) were loaned free of charge by the company (Advanced Telecommunications Research Institute International).

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Doi, S.K., Isumi, A., Yamaoka, Y. et al. The effect of breathing relaxation to improve poor sleep quality in adults using a huggable human-shaped device: a randomized controlled trial. Sleep Breath 28, 429–439 (2024). https://doi.org/10.1007/s11325-023-02858-5

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