Sleep Initiation and Maintenance DisordersNCT05257317
Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
A study testing Osteopathic Medicine in people with Sleep Initiation and Maintenance Disorders, run by Escoles Universitaries Gimbernat at 1 site in Spain.
Trial summary
Insomnia is the most prevalent sleep disorder in society. The first treatment of choice is pharmacology, although it can have secondary effects such as tolerance and dependence, or alter the structure of sleep; therefore, new pathways towards other adjuvant treatments are being established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Osteopathic Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2022to Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic insomnia disorder according to the criteria defined by the ICSD-III (International Classification of Sleep Disorders-3rd edition):
- Problems initiating or maintaining sleep, associated with daytime consequences; and not attributable to environmental circumstances.
- Insomnia lasting more than 3 months, with episodes of at least 3 times a week.
- Regarding the pharmacology or medication indicated for sleep:
- They do not want to take the medication recommended by the doctor who is treating them.
- Do not change their usual drug regimen, if they were already taking medication to sleep.
Show all 13Show fewer
- They are not taxed to take medication.
- Having ruled out other pathologies related to sleep through:
- Respiratory polygraphy to rule out sleep-related respiratory pathologies (SAHS).
- screening to rule out motor sleep disorders.
- screening to rule out circadian sleep disorders.
- screening to rule out serious psychiatric disorders (depression, anxiety, general psychopathology): BDI-II (Beck Depression Inventory), BAI (Beck Anxiety Inventory), SCL-90.
- Obtain a score greater than 7 points (clinical-subclinical insomnia).
Who cannot join
- Obtain a score of less than 7 (clinically insignificant insomnia) in the ISI test (Insomnia Severity Index).
- The result of the respiratory polygraphy is positive, confirming a sleep-disordered breathing.
- The screening tests for the detection of motor sleep disorders, respiratory sleep disorders or circadian disorders are positive.
- The Screening detects serious psychiatric illnesses such as major depressive disorder or bipolar disorders is positive.
- Suffering or having suffered from any central neurological pathology, stroke, aneurysm...
- Having suffered skull fractures.
- Having undergone surgery in the last 6 months and that insomnia has started as a result of it.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, 08174
Maider Sánchez-Padilla, MSc, 0034 93 589 37 27 ext. 216, maider.sanchez@eug.es
About this study
Insomnia is the most prevalent sleep disorder in society. The first treatment of choice is pharmacology, although it can have secondary effects such as tolerance and dependence, or alter the structure of sleep; therefore, new pathways towards other adjuvant treatments are being established. OBJECTIVES: The main objective is "To assess the effectiveness of manual cranial therapy on the quantity and quality of sleep in patients with chronic insomnia." MATERIAL AND METHODS: A randomized clinical trial is designed, with two groups, intervention and placebo, to assess the effectiveness of manual therapy applied to the skull, in the severity of insomnia, and quantity and quality of sleep in patients with sleep disorder. chronic insomnia. Health professionals will be selected from the Department of Occupational Health, with characteristics of chronic insomnia described by the ICSD-III, who do not modify their usual medication regimen (if they take it) and without other pathologies related to sleep that may be causing the insomnia. insomnia Demographic data (age, sex, profession), clinical (BMI, history of previous and family insomnia pathologies, and taking medication for sleep and related disorders), sleep quality questionnaires (PSQI, COS, ISI) will be collected. , stress-insomnia relationship (FISRST-S), and quality of life (SF12), in addition to filling out a sleep diary (through the mobile App) and recording activity through actigraphy, hypnogram (Sleep ProfilerTM); before and after the intervention, and at one and three month follow-up. Each group will receive the offered intervention: cranial manual therapy (intervention) or cranial massage (placebo). The data will be coded and analyzed with the IBM SPSS® version 20 program (or similar)
- Being tested
- Osteopathic Medicine, Placebo therapy
- Keywords
- Sleep Iniciation and Maintenane Disorders, Autonomic Nervous System, Osteopathic Medicine, Muskuloeskeletal Manipulation, Dysominias
- 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.
Osteopathic MedicineOther
Where compression and traction movements will be carried out on these structures.
Technique called CV4, applied on the occipital, and Technique called asynchronous rolling of the temporal bones.
Placebo therapyOther
Circular movements will be induced in a frontal and parietal bones
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | It will consist of osteopathic manual therapy techniques applied to the occipital and temporal bones. Receives: Other: Osteopathic Medicine |
| Placebo | Placebo comparator | It consists of a light contact applied to the cranial vault (frontal and parietal bones) where circular movements will be induced. Receives: Other: Placebo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
With an "Insomnia Severity Index" (ISI). There are seven items. Each item is rated on a scale from 0 to 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28 = most severe insomnia).
Measured: 18 weeks
Secondary outcomes (8)
Sleep Quality
With a "Pittsburgh Sleep Quality Index (PSQI)" It consists of 19 items that analyze: quality, latency, duration, efficiency and sleep disturbances, use of sleeping medication and daytime dysfunction. The scores of the questions allows between 0 and 3 points for each of the seven subscales, where in all cases a score of "0" indicates ease, while a score of "3" indicates severe difficulty within its respective area. The sum of the seven subscales allows obtaining a global score between 0 and 21 for the entire scale, where "0" indicates ease of sleeping and "21" severe difficulty in all areas.
Measured: 18 weeks
Sleep Quality
With a "Cuestionario del Sueño de Oviedo (COS)". It consists of 15 items, 13 of which are grouped into 3 scales:
- Subjective sleep satisfaction (1 item): score from 1 to 7.
- Insomnia (9 items) The scoring range is from 9 to 45, higher score indicate greater severity.
- Hypersomnia (3 items): from 3 to 15 points, higher score indicate greater daytime disability.
Measured: 18 weeks
Vulnerability to stress-related insomnia
With FORD INSOMNIA RESPONSE TO STRESS spanish (FIRST-S). It is a scale that assesses vulnerability to stress-related insomnia. It is a standardized questionnaire with high test-retest reliability, which has been validated as a predictive measure of sleep vulnerability using polysomnographically measured sleep. It is made up of nine items and requires the individual to rate between 1 (not at all common) and 4 (very common) the probability of having sleep disturbance in association with specific and common stressful events or periods of stress that occur during the day or at night .
The total score of the answers obtained is quantified. High scores are indicative of increased vulnerability to stress-related insomnia. The cut-off score to detect individuals with this vulnerability is 19 points or higher, indicating "high-FIRST sleep reactivity."
Measured: 9 weeks
Quality of Life of patients with insomnia
With a 12-items Short-Form Health Survey (SF12). It consists of 12 items from the 8 dimensions of the SF-36 Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1), Body Pain (1), General Health (1). The response options form Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.
For each of the 8 dimensions that it identifies, the items are coded, aggregated and transformed into a scale ranging from 0 (the worst state of health for that dimension) to 100 (the best state of health).
Measured: 18 weeks
Quantity, latency and efficiency of sleep
With a "Sleep Diary"
Measured: 18 weeks
Quantity, latency and efficiency of sleep
With an "Actigraphy record"
Measured: 18 weeks
Hypnogram-Polysomnography - Macro and microstructure of sleep
With a "WachPAt(R) device"
Measured: 18 weeks
Heart Rate Variability
With a "Polar H10 band" and "EliteHRV" app
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Principal investigator, Maider Sánchez Padilla, Escoles Universitaries Gimbernat
- Investigators
- Maider Sánchez-Padilla, MSc, Principal investigator, Escoles Universitaries GimbernatLaura Vigil-Gimenez, PhD, Study director, Corporación Parc TaulíMaria José Masdeu-Margalef, PhD, Study director, Corporación Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257317
- Sponsor's protocol ID
- 2019/302
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The pandemic has delayed the completion of the study and no publication date for the information has been proposed
Publications
Equihua-Benitez AC, Guzman-Vasquez K, Drucker-Colin R. Understanding sleep-wake mechanisms and drug discovery. Expert Opin Drug Discov. 2017 Jul;12(7):643-657. doi: 10.1080/17460441.2017.1329818. Epub 2017 May 22.
PubMed 28511597Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28.
PubMed 19481481Durmer JS, Dinges DF; New Collective Author. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2005 Mar;25(1):117-29. doi: 10.1055/s-2005-867080.
PubMed 15798944Riemann D, Nissen C, Palagini L, Otte A, Perlis ML, Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol. 2015 May;14(5):547-58. doi: 10.1016/S1474-4422(15)00021-6. Epub 2015 Apr 12.
PubMed 25895933Merino-Andreu M, Alvarez-Ruiz de Larrinaga A, Madrid-Perez JA, Martinez-Martinez MA, Puertas-Cuesta FJ, Asencio-Guerra AJ, Romero Santo-Tomas O, Jurado-Luque MJ, Segarra-Isern FJ, Canet-Sanz T, Gimenez-Rodriguez P, Teran-Santos J, Alonso-Alvarez ML, Garcia-Borreguero Diaz-Varela D, Barriuso-Esteban B. [Healthy sleep: evidence and guidelines for action. Official document of the Spanish Sleep Society]. Rev Neurol. 2016 Oct 3;63(s02):1. Spanish.
PubMed 27699758Nofzinger EA, Buysse DJ, Germain A, Price JC, Miewald JM, Kupfer DJ. Functional neuroimaging evidence for hyperarousal in insomnia. Am J Psychiatry. 2004 Nov;161(11):2126-8. doi: 10.1176/appi.ajp.161.11.2126.
PubMed 15514418Halasz P, Bodizs R, Parrino L, Terzano M. Two features of sleep slow waves: homeostatic and reactive aspects--from long term to instant sleep homeostasis. Sleep Med. 2014 Oct;15(10):1184-95. doi: 10.1016/j.sleep.2014.06.006. Epub 2014 Jul 8.
PubMed 25192672Bastien CH, St-Jean G, Morin CM, Turcotte I, Carrier J. Chronic psychophysiological insomnia: hyperarousal and/or inhibition deficits? An ERPs investigation. Sleep. 2008 Jun;31(6):887-98. doi: 10.1093/sleep/31.6.887.
PubMed 18548835Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970.
PubMed 25367475Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
PubMed 17520797Riha RL. Diagnostic approaches to respiratory sleep disorders. J Thorac Dis. 2015 Aug;7(8):1373-84. doi: 10.3978/j.issn.2072-1439.2015.08.28.
PubMed 26380763Thorpy MJ. Classification of sleep disorders. Neurotherapeutics. 2012 Oct;9(4):687-701. doi: 10.1007/s13311-012-0145-6.
PubMed 22976557D'Alonzo GE, Krachman SL. Circadian rhythm sleep disorders. J Am Osteopath Assoc. 2000 Aug;100(8 Suppl):S15-21.
PubMed 11002615Medrano-Martinez P, Ramos-Platon MJ. [Cognitive and emotional alterations in chronic insomnia]. Rev Neurol. 2016 Feb 16;62(4):170-8. Spanish.
PubMed 26860722Nijs J, Mairesse O, Neu D, Leysen L, Danneels L, Cagnie B, Meeus M, Moens M, Ickmans K, Goubert D. Sleep Disturbances in Chronic Pain: Neurobiology, Assessment, and Treatment in Physical Therapist Practice. Phys Ther. 2018 May 1;98(5):325-335. doi: 10.1093/ptj/pzy020.
PubMed 29425327
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
- ClinicalTrials.gov ID
- NCT05257317
- Acronym / sponsor ID
- 2019/302
- Keywords
- Sleep Iniciation and Maintenane Disorders, Autonomic Nervous System, Osteopathic Medicine, Muskuloeskeletal Manipulation, Dysominias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- Feb 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Feb 2022 (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.
Insomnia is the most prevalent sleep disorder in society. The first treatment of choice is pharmacology, although it can have secondary effects such as tolerance and dependence, or alter the structure of sleep; therefore, new pathways towards other adjuvant treatments are being established. OBJECTIVES: The main objective is "To assess the effectiveness of manual cranial therapy on the quantity and quality of sleep in patients with chronic insomnia." MATERIAL AND METHODS: A randomized clinical trial is designed, with two groups, intervention and placebo, to assess the effectiveness of manual therapy applied to the skull, in the severity of insomnia, and quantity and quality of sleep in patients with sleep disorder. chronic insomnia. Health professionals will be selected from the Department of Occupational Health, with characteristics of chronic insomnia described by the ICSD-III, who do not modify their usual medication regimen (if they take it) and without other pathologies related to sleep that may be causing the insomnia. insomnia Demographic data (age, sex, profession), clinical (BMI, history of previous and family insomnia pathologies, and taking medication for sleep and related disorders), sleep quality questionnaires (PSQI, COS, ISI) will be collected. , stress-insomnia relationship (FISRST-S), and quality of life (SF12), in addition to filling out a sleep diary (through the mobile App) and recording activity through actigraphy, hypnogram (Sleep ProfilerTM); before and after the intervention, and at one and three month follow-up. Each group will receive the offered intervention: cranial manual therapy (intervention) or cranial massage (placebo). The data will be coded and analyzed with the IBM SPSS® version 20 program (or similar)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Osteopathic MedicineIt will consist of osteopathic manual therapy techniques applied to the occipital and temporal bones. |
| Placebo | Placebo comparator | Other: Placebo therapyIt consists of a light contact applied to the cranial vault (frontal and parietal bones) where circular movements will be induced. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosed with chronic insomnia disorder according to the criteria defined by the ICSD-III (International Classification of Sleep Disorders-3rd edition):
- Regarding the pharmacology or medication indicated for sleep:
- Having ruled out other pathologies related to sleep through:
- Obtain a score greater than 7 points (clinical-subclinical insomnia).
Key exclusion criteria (7 listed)
- Obtain a score of less than 7 (clinically insignificant insomnia) in the ISI test (Insomnia Severity Index).
- The result of the respiratory polygraphy is positive, confirming a sleep-disordered breathing.
- The screening tests for the detection of motor sleep disorders, respiratory sleep disorders or circadian disorders are positive.
- The Screening detects serious psychiatric illnesses such as major depressive disorder or bipolar disorders is positive.
- Suffering or having suffered from any central neurological pathology, stroke, aneurysm...
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 |
|---|---|---|
| Osteopathic MedicineWhere compression and traction movements will be carried out on these structures. Technique called CV4, applied on the occipital, and Technique called asynchronous rolling of the temporal bones. | Other | Intervention |
| Placebo therapyCircular movements will be induced in a frontal and parietal bones | Other | Placebo |
Primary outcome
Insomnia Severity
Time frame: 18 weeks
With an "Insomnia Severity Index" (ISI). There are seven items. Each item is rated on a scale from 0 to 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28 = most severe insomnia).
8 secondary outcomes
Sleep Quality
Time frame: 18 weeks
Sleep Quality
Time frame: 18 weeks
Vulnerability to stress-related insomnia
Time frame: 9 weeks
Quality of Life of patients with insomnia
Time frame: 18 weeks
Quantity, latency and efficiency of sleep
Time frame: 18 weeks
Quantity, latency and efficiency of sleep
Time frame: 18 weeks
Hypnogram-Polysomnography - Macro and microstructure of sleep
Time frame: 18 weeks
Heart Rate Variability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Background: PubMed 28511597Equihua-Benitez AC, Guzman-Vasquez K, Drucker-Colin R. Understanding sleep-wake mechanisms and drug discovery. Expert Opin Drug Discov. 2017 Jul;12(7):643-657. doi: 10.1080/17460441.2017.1329818. Epub 2017 May 22.
- Background: PubMed 19481481Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28.
- Background: PubMed 15798944Durmer JS, Dinges DF; New Collective Author. Neurocognitive consequences of sleep deprivation. Semin Neurol. 2005 Mar;25(1):117-29. doi: 10.1055/s-2005-867080.
- Background: PubMed 25895933Riemann D, Nissen C, Palagini L, Otte A, Perlis ML, Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol. 2015 May;14(5):547-58. doi: 10.1016/S1474-4422(15)00021-6. Epub 2015 Apr 12.
- Background: PubMed 27699758Merino-Andreu M, Alvarez-Ruiz de Larrinaga A, Madrid-Perez JA, Martinez-Martinez MA, Puertas-Cuesta FJ, Asencio-Guerra AJ, Romero Santo-Tomas O, Jurado-Luque MJ, Segarra-Isern FJ, Canet-Sanz T, Gimenez-Rodriguez P, Teran-Santos J, Alonso-Alvarez ML, Garcia-Borreguero Diaz-Varela D, Barriuso-Esteban B. [Healthy sleep: evidence and guidelines for action. Official document of the Spanish Sleep Society]. Rev Neurol. 2016 Oct 3;63(s02):1. Spanish.
- Background: PubMed 15514418Nofzinger EA, Buysse DJ, Germain A, Price JC, Miewald JM, Kupfer DJ. Functional neuroimaging evidence for hyperarousal in insomnia. Am J Psychiatry. 2004 Nov;161(11):2126-8. doi: 10.1176/appi.ajp.161.11.2126.
- Background: PubMed 25192672Halasz P, Bodizs R, Parrino L, Terzano M. Two features of sleep slow waves: homeostatic and reactive aspects--from long term to instant sleep homeostasis. Sleep Med. 2014 Oct;15(10):1184-95. doi: 10.1016/j.sleep.2014.06.006. Epub 2014 Jul 8.
- Background: PubMed 18548835Bastien CH, St-Jean G, Morin CM, Turcotte I, Carrier J. Chronic psychophysiological insomnia: hyperarousal and/or inhibition deficits? An ERPs investigation. Sleep. 2008 Jun;31(6):887-98. doi: 10.1093/sleep/31.6.887.
- Background: PubMed 25367475Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970.
- Background: PubMed 17520797Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
- Background: PubMed 26380763Riha RL. Diagnostic approaches to respiratory sleep disorders. J Thorac Dis. 2015 Aug;7(8):1373-84. doi: 10.3978/j.issn.2072-1439.2015.08.28.
- Background: PubMed 22976557Thorpy MJ. Classification of sleep disorders. Neurotherapeutics. 2012 Oct;9(4):687-701. doi: 10.1007/s13311-012-0145-6.
- Individual participant dataSharing planned: No. The pandemic has delayed the completion of the study and no publication date for the information has been proposed
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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.
Maider Sánchez-Padilla, MSc principal investigator
Escoles Universitaries Gimbernat
Laura Vigil-Gimenez, PhD study director
Corporación Parc Taulí
Maria José Masdeu-Margalef, PhD study director
Corporación Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Medicine in people with Sleep Initiation and Maintenance Disorders, run by Escoles Universitaries Gimbernat at 1 site in Spain.
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 13 inclusion and 7 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 25 Feb 2022. 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 Spain. 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 Maider Sánchez-Padilla, MSc (0034 93 589 37 27 ext. 216, maider.sanchez@eug.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: 18 weeks). 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 NCT05257317, which also lists 48 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 25 Feb 2022.