Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia

Healthy Clinical Trial

Official title:

Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899972
• Other study ID #: OST1-007
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: Natália MO Campelo, PhD
• Phone: 938674365
• Email: ncampelo.estsp.ipp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Description:

Humans spend about a third of their lives sleeping, but most individuals know little about sleep. Sleep deprivation, which is a universal necessity, has serious physiological consequences.

Based on behavioral and physiological criteria, human sleep is divided into two phases: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM).

NREM sleep corresponds to 75% to 80% of sleep and REM approximately 20% to 25% of sleep, existing between four to six episodes.

Sleep disorders are among the most common health problems, and yet they are often neglected. It is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity.

According to the International Classification of Sleep Disorders (ICSD) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders.

Insomnia is a sleep disorder defined by difficulty falling asleep, staying asleep, or both. It can cause significant distress and impair daily tasks. The symptoms of insomnia are expressed by having difficulty falling asleep, waking up frequently during the night, waking up very early on a daily basis, and tiredness already present upon waking up.

Osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes (Henley, Ivins, Mills, Wen, & Benjamin, 2008). Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Have sleep disorders (insomnia);

• Volunteers between 18 and 30 years of age.

Exclusion Criteria:

• Attending the 3rd or 4th year of the Osteopathy Course;

• Present fever (axillary or oral temperature higher than 37.5º C);

• Have a history of skull fracture;

• Have a history of bleeding and intracranial hemorrhage;

• Have a diagnosis of convulsion.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Placebo technique
With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The contact is made with the hands on the shoulder blades of the volunteer for 6 minutes.
• Suboccipital inhibition technique
With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator starts by placing both hands under the patient's head in the occipital region. After palpating the suboccipital muscles, the investigator uses the second, third and fourth fingers of both hands flexed against the muscle belly and remains in this position.
• Frontal lift technique
With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions the tips of both index fingers on either side of the metopic suture while the third finger remains resting on the frontal bone so that the tips of the fourth fingers contact the zygomatic processes bilaterally. A slight pressure is applied with the index fingers and an anterior pressure is performed.
• Parietal lift technique
With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator places the palms on the lateral edges of the parietal bones and the thumbs crossed at the sagittal suture. First, a medial pressure is administered with the second, third and fourth fingers and then a cephalic traction is performed.
• IV ventricle technique
With the volunteer in a supine position, the investigator is sitting position at the patient's bedside. The investigator positions his hands in a shell and thumbs together at the level of the spinous apophyses of the patient's second or third cervical vertebra.

Locations

Country	Name	City	State
Portugal	Escola Superior da Saúde do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (14)

Bruce ES, Lunt L, McDonagh JE. Sleep in adolescents and young adults. Clin Med (Lond). 2017 Oct;17(5):424-428. doi: 10.7861/clinmedicine.17-5-424. — View Citation

Byun JI, Shin YY, Chung SE, Shin WC. Safety and Efficacy of Gamma-Aminobutyric Acid from Fermented Rice Germ in Patients with Insomnia Symptoms: A Randomized, Double-Blind Trial. J Clin Neurol. 2018 Jul;14(3):291-295. doi: 10.3988/jcn.2018.14.3.291. Epub 2018 Apr 27. — View Citation

Chigome, Audrey & Nhira, Sandra & Meyer, Johanna. (2018). An overview of insomnia and its management. SA Pharmaceutical Journal. 85. 32-38.

Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103. — View Citation

Del Rio Joao KA, Becker NB, de Neves Jesus S, Isabel Santos Martins R. Validation of the Portuguese version of the Pittsburgh Sleep Quality Index (PSQI-PT). Psychiatry Res. 2017 Jan;247:225-229. doi: 10.1016/j.psychres.2016.11.042. Epub 2016 Nov 28. — View Citation

Hasan F, Tu YK, Yang CM, James Gordon C, Wu D, Lee HC, Yuliana LT, Herawati L, Chen TJ, Chiu HY. Comparative efficacy of digital cognitive behavioral therapy for insomnia: A systematic review and network meta-analysis. Sleep Med Rev. 2022 Feb;61:101567. doi: 10.1016/j.smrv.2021.101567. Epub 2021 Nov 10. — View Citation

Henley CE, Ivins D, Mills M, Wen FK, Benjamin BA. Osteopathic manipulative treatment and its relationship to autonomic nervous system activity as demonstrated by heart rate variability: a repeated measures study. Osteopath Med Prim Care. 2008 Jun 5;2:7. doi: 10.1186/1750-4732-2-7. — View Citation

Hirshkowitz M. Normal human sleep: an overview. Med Clin North Am. 2004 May;88(3):551-65, vii. doi: 10.1016/j.mcna.2004.01.001. No abstract available. — View Citation

K Pavlova M, Latreille V. Sleep Disorders. Am J Med. 2019 Mar;132(3):292-299. doi: 10.1016/j.amjmed.2018.09.021. Epub 2018 Oct 4. — View Citation

McArdle N, Ward SV, Bucks RS, Maddison K, Smith A, Huang RC, Pennell CE, Hillman DR, Eastwood PR. The prevalence of common sleep disorders in young adults: a descriptive population-based study. Sleep. 2020 Oct 13;43(10):zsaa072. doi: 10.1093/sleep/zsaa072. — View Citation

Medalie L, Cifu AS. Management of Chronic Insomnia Disorder in Adults. JAMA. 2017 Feb 21;317(7):762-763. doi: 10.1001/jama.2016.19004. No abstract available. — View Citation

Nobles, T., Bach, A., & Boesler, D. (2016). Case report of osteopathic treatment of insomnia and traumatic anhidrosis. International Journal of Osteopathic Medicine, 21, 58-61. https://doi.org/10.1016/j.ijosm.2016.01.006

Perdereau-Noel M, Saliou P, Vic P. [Prevalence of teenage sleeping disorders]. Arch Pediatr. 2017 Apr;24(4):336-345. doi: 10.1016/j.arcped.2017.01.009. Epub 2017 Feb 24. French. — View Citation

van de Wouw E, Evenhuis HM, Echteld MA. Prevalence, associated factors and treatment of sleep problems in adults with intellectual disability: a systematic review. Res Dev Disabil. 2012 Jul-Aug;33(4):1310-32. doi: 10.1016/j.ridd.2012.03.003. Epub 2012 Mar 30. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.	7 days post-intervention

External Links

•   Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2017