InsomniaNCT06363799
Osteopathic Protocol for Insomnia in College Students
A study testing 4th ventricle compression technique and Diaphragmatic breathing technique in people with Insomnia, run by Escola Superior de Tecnologia da Saúde do Porto.
Trial summary
In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Insomnia
- What is being tested?
- 4th ventricle compression technique and Diaphragmatic breathing technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being a college student
- insomnia presence
- willingness to complete a full study period
- understanding and acceptance of the study procedures
- willingness to refrain from other intervention during the study period
- availability to keep a diary (sleep and mood throughout the day)
Who cannot join
- having suffered a stroke or aneurysm
- hypertension
- fractured the base of the skull
- pregnancy
- active insomnia treatment
- participation in other simultaneous studies
- regular use of sleep medication
- have participated in complementary therapies for insomnia recently
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Osteopathic Protocol for Insomnia in College Students: RCT
In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique.
Read the detailed description
Insomnia is a sleep disorder defined by persistent difficulty in initiating, maintaining or consolidating sleep. It can also be defined by early morning awakenings or having a dissatisfied sleep quality, even if you have plenty of time and a suitable environment to a restful sleep. This difficulty sleeping must be experienced at least 3 nights per week, for 3 consecutive months. This can often lead to symptoms such as fatigue, irritability and difficulty concentrating during the day.
Both compression of 4th ventricle and diaphragmatic techniques have been proven to help lower the tone of the sympathetic nervous system, restoring a normal respiratory mechanism.
It is anticipated that the combination of 4th ventricle technique and diaphragmatic breathing may result in a significant reduction in insomnia symptoms, providing study participants with a notable improvement in the quality of sleep and, therefore, in their general well-being.
- Conditions
- Insomnia
- Being tested
- 4th ventricle compression technique, Sham Technique, Diaphragmatic breathing technique
- Keywords
- CV4, Diaphragmatic breathing, Insomnia, Osteopathy, College Students
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4th ventricle compression techniqueOther
For the CV4 the mediator's hands assume a specific position: one on top of the other, with the tips of the thumbs joined together in a "V" shape, positioned approximately on the process spinous between the patient's second and third cervical vertebrae, pointing downwards.
Sham TechniqueOther
The participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 5 minutes.
Diaphragmatic breathing techniqueOther
For the diaphragmatic breathing the participant will place one hand on their chest and the other over their abdomen. Both of their hands will be overlapped by the mediator's, so it is easier to feel the correct breathing movements to be performed.
| Study group | Role | What they receive |
|---|---|---|
| 4th ventricle compression technique | Experimental | Experimental:
4th ventricle compression technique Receives: Other: 4th ventricle compression technique |
| Diaphragmatic breathing technique | Experimental | Experimental:
Diaphragmatic breathing technique Receives: Other: Diaphragmatic breathing technique |
| Sham Tecnhique | Placebo comparator | Placebo Comparator:
Sham Technique Receives: Other: Sham Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score
The insomnia episodes and symptoms are measured using the Pittsburgh questionnaire and it will be applied one month after the first intervention. It is expected that the Pittsburgh score decreases after the intervention is done. A Pittsburgh score higher than 5 is considered to be coincident with a bad sleeping quality. A Pittsburgh score lower than 5 is considered to be coincident with a good sleeping quality. This score goes up to 21 points.
Measured: One month after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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 da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363799
- Sponsor's protocol ID
- OST1_010
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bordoni B, Escher AR Jr. Osteopathic Principles: The Inspiration of Every Science Is Its Change. Cureus. 2021 Jan 4;13(1):e12478. doi: 10.7759/cureus.12478.
PubMed 33425556Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
PubMed 26199632Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
PubMed 27553981Consolo, K., Fusner, S., & Staib, S. (3 de Outubro de 2008). Effects of diaphragmatic breathing on stress levels of nursing students. pp. 67-71.
DiGiovanna , E., Schiowitz, S., & Dowling, D. (2020). An Osteopathic Approach to Diagnosis and Treatment, Fourth Edition. Lippincott Williams & Wilrins.
Homistek, C., & Doty, H. (2021). Insomnia Diagnosis and Management: An Osteopathic Approach. Osteopathic Family Physician, 31-36.
Lande RG, Gragnani C. Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc. 2010 Dec;110(12):695-701.
PubMed 21178150Liem, T., McPartland, J., & Skinner, E. (2005). Cranial Osteopathy - Principles and Practice. Elsevier Health Sciences.
Liu D, Kahathuduwa C, Vazsonyi AT. The Pittsburgh Sleep Quality Index (PSQI): Psychometric and clinical risk score applications among college students. Psychol Assess. 2021 Sep;33(9):816-826. doi: 10.1037/pas0001027. Epub 2021 May 20.
PubMed 34014747Manzar MD, BaHammam AS, Hameed UA, Spence DW, Pandi-Perumal SR, Moscovitch A, Streiner DL. Dimensionality of the Pittsburgh Sleep Quality Index: a systematic review. Health Qual Life Outcomes. 2018 May 9;16(1):89. doi: 10.1186/s12955-018-0915-x.
PubMed 29743066McCarley RW. Neurobiology of REM and NREM sleep. Sleep Med. 2007 Jun;8(4):302-30. doi: 10.1016/j.sleep.2007.03.005. Epub 2007 Apr 30.
PubMed 17468046Milnes, K., & Moran, R. (17 de Janeiro de 2007). Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: A preliminary investigation. pp. 8-17.
Morin M., C., Beaulieu-Bonneau, S., & Cheung, J. (2019). Treatment of Insomnia. Em Handbook of Sleep Disorders in Medical Conditions. Elsevier.
Pacheco, D., & Dimitriu, A. (2022). Symptoms of Insomnia.
Zitser J, Allen IE, Falgas N, Le MM, Neylan TC, Kramer JH, Walsh CM. Pittsburgh Sleep Quality Index (PSQI) responses are modulated by total sleep time and wake after sleep onset in healthy older adults. PLoS One. 2022 Jun 24;17(6):e0270095. doi: 10.1371/journal.pone.0270095. eCollection 2022.
PubMed 35749529
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Protocol for Insomnia in College Students: RCT
- ClinicalTrials.gov ID
- NCT06363799
- Acronym / sponsor ID
- OST1_010
- Conditions
- Insomnia
- Keywords
- CV4, Diaphragmatic breathing, Insomnia, Osteopathy, College Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Apr 2024 (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.
In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique.
Detailed description
Insomnia is a sleep disorder defined by persistent difficulty in initiating, maintaining or consolidating sleep. It can also be defined by early morning awakenings or having a dissatisfied sleep quality, even if you have plenty of time and a suitable environment to a restful sleep. This difficulty sleeping must be experienced at least 3 nights per week, for 3 consecutive months. This can often lead to symptoms such as fatigue, irritability and difficulty concentrating during the day.
Both compression of 4th ventricle and diaphragmatic techniques have been proven to help lower the tone of the sympathetic nervous system, restoring a normal respiratory mechanism.
It is anticipated that the combination of 4th ventricle technique and diaphragmatic breathing may result in a significant reduction in insomnia symptoms, providing study participants with a notable improvement in the quality of sleep and, therefore, in their general well-being.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4th ventricle compression technique | Experimental | Other: 4th ventricle compression techniqueExperimental: 4th ventricle compression technique |
| Diaphragmatic breathing technique | Experimental | Other: Diaphragmatic breathing techniqueExperimental: Diaphragmatic breathing technique |
| Sham Tecnhique | Placebo comparator | Other: Sham TechniquePlacebo Comparator: Sham Technique |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- being a college student
- insomnia presence
- willingness to complete a full study period
- understanding and acceptance of the study procedures
- willingness to refrain from other intervention during the study period
Key exclusion criteria (8 listed)
- having suffered a stroke or aneurysm
- hypertension
- fractured the base of the skull
- pregnancy
- active insomnia treatment
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 |
|---|---|---|
| 4th ventricle compression techniqueFor the CV4 the mediator's hands assume a specific position: one on top of the other, with the tips of the thumbs joined together in a "V" shape, positioned approximately on the process spinous between the patient's second and third cervical vertebrae, pointing downwards. | Other | 4th ventricle compression technique |
| Sham TechniqueThe participant is instructed to lie down in the supine position while the mediator assumes a position at the head of the table and places their hands on the participant's shoulders. This technique is performed for 5 minutes. | Other | Sham Tecnhique |
| Diaphragmatic breathing techniqueFor the diaphragmatic breathing the participant will place one hand on their chest and the other over their abdomen. Both of their hands will be overlapped by the mediator's, so it is easier to feel the correct breathing movements to be performed. | Other | Diaphragmatic breathing technique |
Primary outcome
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score
Time frame: One month after the first intervention
The insomnia episodes and symptoms are measured using the Pittsburgh questionnaire and it will be applied one month after the first intervention. It is expected that the Pittsburgh score decreases after the intervention is done. A Pittsburgh score higher than 5 is considered to be coincident with a bad sleeping quality. A Pittsburgh score lower than 5 is considered to be coincident with a good sleeping quality. This score goes up to 21 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 33425556Bordoni B, Escher AR Jr. Osteopathic Principles: The Inspiration of Every Science Is Its Change. Cureus. 2021 Jan 4;13(1):e12478. doi: 10.7759/cureus.12478.
- Background: PubMed 26199632Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
- Background: PubMed 27553981Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
- BackgroundConsolo, K., Fusner, S., & Staib, S. (3 de Outubro de 2008). Effects of diaphragmatic breathing on stress levels of nursing students. pp. 67-71.
- BackgroundDiGiovanna , E., Schiowitz, S., & Dowling, D. (2020). An Osteopathic Approach to Diagnosis and Treatment, Fourth Edition. Lippincott Williams & Wilrins.
- BackgroundHomistek, C., & Doty, H. (2021). Insomnia Diagnosis and Management: An Osteopathic Approach. Osteopathic Family Physician, 31-36.
- Background: PubMed 21178150Lande RG, Gragnani C. Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc. 2010 Dec;110(12):695-701.
- BackgroundLiem, T., McPartland, J., & Skinner, E. (2005). Cranial Osteopathy - Principles and Practice. Elsevier Health Sciences.
- Background: PubMed 34014747Liu D, Kahathuduwa C, Vazsonyi AT. The Pittsburgh Sleep Quality Index (PSQI): Psychometric and clinical risk score applications among college students. Psychol Assess. 2021 Sep;33(9):816-826. doi: 10.1037/pas0001027. Epub 2021 May 20.
- Background: PubMed 29743066Manzar MD, BaHammam AS, Hameed UA, Spence DW, Pandi-Perumal SR, Moscovitch A, Streiner DL. Dimensionality of the Pittsburgh Sleep Quality Index: a systematic review. Health Qual Life Outcomes. 2018 May 9;16(1):89. doi: 10.1186/s12955-018-0915-x.
- Background: PubMed 17468046McCarley RW. Neurobiology of REM and NREM sleep. Sleep Med. 2007 Jun;8(4):302-30. doi: 10.1016/j.sleep.2007.03.005. Epub 2007 Apr 30.
- BackgroundMilnes, K., & Moran, R. (17 de Janeiro de 2007). Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: A preliminary investigation. pp. 8-17.
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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 da Saúde do Porto
Questions about this trial
What is this clinical trial studying?
A study testing 4th ventricle compression technique and Diaphragmatic breathing technique in people with Insomnia, run by Escola Superior de Tecnologia da Saúde do Porto.
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 6 inclusion and 8 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (+35122 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score (time frame: One month after the first 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 NCT06363799, which also lists 15 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 30 Apr 2024.