HealthyNCT05899972
Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep Quality in Young Adults With Insomnia
A study testing Suboccipital inhibition technique, Frontal lift technique and Parietal lift technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Suboccipital inhibition technique, Frontal lift technique and Parietal lift technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2024to 31 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have sleep disorders (insomnia);
- Volunteers between 18 and 30 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Placebo technique, Suboccipital inhibition technique, Frontal lift technique, Parietal lift technique, IV ventricle technique
- Keywords
- Osteopathy, Insomnia, Sleep disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo techniqueOther
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 techniqueOther
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 techniqueOther
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 techniqueOther
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 techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Politécnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899972
- Sponsor's protocol ID
- OST1-007
- Status last verified
- Apr 2024
- First submitted
- 31 May 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30292731McArdle 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.
PubMed 32280974Perdereau-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.
PubMed 28242150Bruce 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.
PubMed 28974591Hirshkowitz 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.
PubMed 15087204van 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.
PubMed 22502859Del 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.
PubMed 27923147Medalie 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.
PubMed 28241342Chigome, 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.
PubMed 15750368Henley 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.
PubMed 18534024Byun 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.
PubMed 29856155Nobles, 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
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.
PubMed 34902820
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05899972
- Acronym / sponsor ID
- OST1-007
- Conditions
- Healthy
- Keywords
- Osteopathy, Insomnia, Sleep disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group | Experimental | Other: Suboccipital inhibition technique, Other: Frontal lift technique, Other: Parietal lift technique, Other: IV ventricle techniqueThe 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. |
| Control group | Placebo comparator | Other: Placebo techniqueFor the control group the placebo technique will be applied for 6 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have sleep disorders (insomnia);
- Volunteers between 18 and 30 years of age.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo techniqueWith 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. | Other | Control group |
| Suboccipital inhibition techniqueWith 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. | Other | Experimental: Experimental group |
| Frontal lift techniqueWith 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. | Other | Experimental: Experimental group |
| Parietal lift techniqueWith 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. | Other | Experimental: Experimental group |
| IV ventricle techniqueWith 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. | Other | Experimental: Experimental group |
Primary outcome
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
Time frame: 7 days post-intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 30292731K 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.
- Background: PubMed 32280974McArdle 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.
- Background: PubMed 28242150Perdereau-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.
- Background: PubMed 28974591Bruce 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.
- Background: PubMed 15087204Hirshkowitz 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.
- Background: PubMed 22502859van 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.
- Background: PubMed 27923147Del 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.
- Background: PubMed 28241342Medalie 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.
- BackgroundChigome, Audrey & Nhira, Sandra & Meyer, Johanna. (2018). An overview of insomnia and its management. SA Pharmaceutical Journal. 85. 32-38.
- Background: PubMed 15750368Cutler 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.
- Background: PubMed 18534024Henley 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.
- Background: PubMed 29856155Byun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Politécnico do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital inhibition technique, Frontal lift technique and Parietal lift technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (938674365 ext. +351, ncampelo.estsp.ipp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index (time frame: 7 days post-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 NCT05899972, which also lists 14 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 2 Apr 2024.