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

NCT05899972 | Not Yet Recruiting DMC

• 1 other identifier: OST1-007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Osteopathy; Insomnia; Sleep disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental: Experimental group

EXPERIMENTAL

The protocol is initiated by the suboccipital inhibition technique, with an average duration of three minutes. Afterwards, the frontal lift and parietal lift techniques were performed, which lasted an average of five minutes, being two and a half minutes for each one. Finally, the IV ventricle technique was performed, with an average duration of three minutes.

Other: Suboccipital inhibition technique; Other: Frontal lift technique; Other: Parietal lift technique; Other: IV ventricle technique

Control group

PLACEBO COMPARATOR

For the control group the placebo technique will be applied for 6 minutes.

Other: Placebo technique

Interventions

Placebo technique OTHER

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.

Control group

Suboccipital inhibition technique OTHER

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.

Experimental: Experimental group

Frontal lift technique OTHER

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.

Experimental: Experimental group

Parietal lift technique OTHER

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.

Experimental: Experimental group

IV ventricle technique OTHER

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.

Experimental: Experimental group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have sleep disorders (insomnia);
• Volunteers between 18 and 30 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (14)

• 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.

  PMID: 30292731 BACKGROUND

• 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.

  PMID: 32280974 BACKGROUND

• 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.

  PMID: 28242150 BACKGROUND

• 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.

  PMID: 28974591 BACKGROUND

• 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.

  PMID: 15087204 BACKGROUND

• 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.

  PMID: 22502859 BACKGROUND

• 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.

  PMID: 27923147 BACKGROUND

• 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.

  PMID: 28241342 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15750368 BACKGROUND

• 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.

  PMID: 18534024 BACKGROUND

• 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.

  PMID: 29856155 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34902820 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Natália MO Campelo, PhD

  Escola Superior de Saúde do Politécnico do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

938674365; ncampelo.estsp.ipp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the distribution of the volunteers to the groups, the participants chose between two numbered envelopes, opaque and sealed, in order to guarantee the confidentiality of the allocation, to which group they belonged. Inside each envelope is a piece of paper with the group, control group or intervention group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 12, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)