Sleep ApneaNCT04246294
Sleep and Pain Sensitivity
An observational study of Sleep Apnea and Chronic Pain Syndrome, run by Aalborg University at 1 site in Denmark.
Trial summary
This project will assess patients with diagnosed obstructive sleep apnea, to investigate the impact of poor sleep on central pain mechanisms. Furthermore, the project will explore if restoring good sleep hygiene can improve the central pain mechanisms that may be associated with the risk of chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Chronic Pain Syndrome
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 1 Oct 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women presenting with an apnea-hypopnea (AHI) index > 15 (moderate-to-severe sleep apnea) measured by cardiorespiratory monitoring (CRM) [10] and scheduled for treatment at Søvncenter Nord
Who may be able to join
- Men and women presenting with an apnea-hypopnea (AHI) index > 15 (moderate-to-severe sleep apnea) measured by cardiorespiratory monitoring (CRM) and scheduled for treatment at Søvncenter Nord
- Age 18-80
Who cannot join
- Pregnancy
- Intake of drugs labelled with the red warning triangle and misuse of cannabis and opioids
- No previous or current neurologic or mental illnesses
- Lack of ability to cooperate
- Non-fluent in Danish (reading, speaking, and comprehension)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otorhinolaryngology, Sleep Center North, Aalborg University Hospital
Aalborg, North Denmark, 9000
About this study
This project will assess patients with diagnosed obstructive sleep apnea, to investigate the impact of poor sleep on central pain mechanisms. Furthermore, the project will explore if restoring good sleep hygiene can improve the central pain mechanisms that may be associated with the risk of chronic pain.
Read the detailed description
Chronic pain affects approx. 20% of the world's population and greatly affects the quality of life of the patients. Recent studies have found that multiple chronic pain patients are characterized by central sensitization and other studies have even found that the degree of central sensitization might be important for pain relieving effects to, e.g., surgery or pharmaceutical treatment. These studies highlight the importance of assessing central sensitization but also indicate that central sensitization can be influenced by multiple factors and it is deemed important to assess such factors in experimental and clinical settings to improve our understanding of the field.
Sleep impairment and the effects on central pain pathways One common complaint among chronic pain patients is that their sleep is affected. It is estimated that at least 50% of chronic pain patients also suffer from sleep disturbances. This is alarming since sleep is well-known to provide neural maturation, facilitate learning, memory, cognition, and general productivity and a lack of sleep impact all of these important processes. Furthermore, earlier studies have shown that partial and total sleep deprivation affect even healthy participants and impair both peripheral and central pain pathways and may indicate that regular sleep is important to maintain a proper healthy response to pain. This notion is supported by evidence showing an association between sleep impairment (e.g. partial or total sleep deprivation) and impaired conditioned pain modulation (CPM), which is the human surrogate model for diffuse noxious inhibitory control. It is also well-established that CPM is impaired in chronic pain patients suffering from back pain, fibromyalgia, or severe knee osteoarthritis (OA). Davies et al. demonstrated that restoring sleep could predict resolution of chronic widespread pain. However, the underlying mechanisms linking impaired sleep and a reduction in pain inhibition are still unclear. Certain neurotransmitters such as serotonin and brain areas such as the periaqueductal gray matter are known to modulate both sleep stages and nociception, and may partly explain the association between impaired sleep and reduction in pain inhibition.
Nonetheless, little is known about the effect of sleep impairment on central pain mechanisms in clinical cohorts. This is important since it is still unclear if restoring a good quality of sleep can modulate the central pain pathway changes known to occur when having impaired sleep and/or chronic pain.
One approach to this question is to assess patients known to suffer from sleep impairment. In this respect, obstructive sleep apnea (OSA) patients are known to present with worsened sleep due to the collapse of the pharyngeal musculature throughout the night. This leads to excessive daytime sleepiness and a decrease in quality of life. Furthermore, pain tolerance has been shown to be decreased in elderly who are diagnosed with OSA. However, little is known about OSA patients and pain sensitivity, and if the sleep impairment also affects the central pain pathways. If so, this may provide an important first step in understanding the possible benefit of restoring restoring normal regular sleep, as routinely achieved through gold standard treatment, and if this can modulate central changes known to occur in chronic pain patients.
Therefore, this project will focus on obstructive sleep apnea (OSA) patients to investigate if central pain mechanisms are affected by poor sleep and if golden standard sleep therapy through continuous positive airway pressure (CPAP) improves central pain mechanisms.
- Conditions
- Sleep Apnea, Chronic Pain Syndrome
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- Sleep Apnea, Continuous Positive Airway Pressure, Temporal Summation of Pain, Conditioned Pain Modulation, Pain Catastrophizing, Pain Detect, Longitudinal, follow-up
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
CPAP is golden standard treatment for moderate-to-severe sleep apnea with high compliance, effectiveness, and cost-effectiveness.
There will be no interference with standard care.
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea patients | This group of patients will have been monitored over night with cardiorespiratory monitoring (CRM). CRM enables the physician to establish an Apnea-Hypopnea Index (AHI) which will be used for diagnosis. An AHI > 15 is considered moderate-to-severe sleep apnea, and this is the focus group of patients in the current project.
These patients will be followed for 12 months during continuous positive airway pressure (CPAP) treatment. Adherence to the CPAP treatment will be closely monitored. Receives: Device: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime sleepiness due to sleep apnea
Daytime sleepiness as assessed by Epworth Sleepiness Scale, will be evaluated as a change from before treatment initiation (min value: 0 (no daily sleepiness); max value (24) - higher score associated with increased sleepiness)
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Secondary outcomes (5)
Change in pain inihibition and facilitation
Cuff-algometry will be used to assess pain inhibition and facilitation, which are human surrogate models for central pain mechanisms. For this, mechanical pressure will be applied to the lower dominant and non-dominant leg. Pain inhibition will be calculated as the difference in mechanical pressure threshold and tolerance on the dominant leg, with and without a conditioning pressure applied to the non-dominant leg. Furthermore, pain facilitation will be assessed by applying 10 rapid mechanical stimuli in succession to the dominant lower leg, at the same pressure intensity.
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
PainDetect
Questionnaire for occurrence of neuropathic-like symptoms. The scale ranges from 0-38 based on 9 items. A score > 19 indicates that there are neuropathic-like symptoms, whereas scores < 12 suggest nociceptive symptoms. Scores between 13 and 18 are indicative of unclear symptoms.
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Pain Catastrophizing Scale
Questionnaire for assessing level of pain catastrophizing thoughts. The scale ranges from 0-52, where scores > 30 indicates clinical pain catastrophizing. The scale consists of 13 items which are scored from 0-4. This scale is validated in both chronic pain patients, and pain-free individuals.
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Pain intensity
Evaluation of the presence of pain. The scale is based on a 0-10 score, where 0 represents no pain, and 10 represents worst pain imaginable. The patients will be asked to indicate whether they have pain at the time of inclusion, at 1 month, and 12 months after treatment initiation.
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Continuous Positive Airway Pressure compliance (percentage who continues using the device for the optimum amount of time each night) and adherence (the percentage of patients who abandon treatment completely)
Usage of the CPAP treatment. Compliance will be based on the percentage of patients that continue using the treatment device for more than 4 hrs each night. This will be assessed throughout the study period to ensure sufficient sample size and subgrouping of compliant and non-compliant patients. Patients will be asked whether or not they still use the device and if so, how many hours a night. Adherence will be assessed by the total amount of patients who abandon treatment throughout the project period.
Measured: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Feb 2020
- Primary completion1 May 2022
- Study completion1 Oct 2022
Why it stopped: Recruitment was made near impossible due to circumstances surrounding the epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Dennis Boye Larsen, Aalborg University
- Investigators
- Dennis B Larsen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246294
- Sponsor's protocol ID
- N-20190044
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Pain Sensitivity
- ClinicalTrials.gov ID
- NCT04246294
- Acronym / sponsor ID
- N-20190044
- Conditions
- Sleep Apnea, Chronic Pain Syndrome
- Keywords
- Sleep Apnea, Continuous Positive Airway Pressure, Temporal Summation of Pain, Conditioned Pain Modulation, Pain Catastrophizing, Pain Detect, Longitudinal, follow-up
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment was made near impossible due to circumstances surrounding the epidemic
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Jan 2020 (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.
This project will assess patients with diagnosed obstructive sleep apnea, to investigate the impact of poor sleep on central pain mechanisms. Furthermore, the project will explore if restoring good sleep hygiene can improve the central pain mechanisms that may be associated with the risk of chronic pain.
Detailed description
Chronic pain affects approx. 20% of the world's population and greatly affects the quality of life of the patients. Recent studies have found that multiple chronic pain patients are characterized by central sensitization and other studies have even found that the degree of central sensitization might be important for pain relieving effects to, e.g., surgery or pharmaceutical treatment. These studies highlight the importance of assessing central sensitization but also indicate that central sensitization can be influenced by multiple factors and it is deemed important to assess such factors in experimental and clinical settings to improve our understanding of the field.
Sleep impairment and the effects on central pain pathways One common complaint among chronic pain patients is that their sleep is affected. It is estimated that at least 50% of chronic pain patients also suffer from sleep disturbances. This is alarming since sleep is well-known to provide neural maturation, facilitate learning, memory, cognition, and general productivity and a lack of sleep impact all of these important processes. Furthermore, earlier studies have shown that partial and total sleep deprivation affect even healthy participants and impair both peripheral and central pain pathways and may indicate that regular sleep is important to maintain a proper healthy response to pain. This notion is supported by evidence showing an association between sleep impairment (e.g. partial or total sleep deprivation) and impaired conditioned pain modulation (CPM), which is the human surrogate model for diffuse noxious inhibitory control. It is also well-established that CPM is impaired in chronic pain patients suffering from back pain, fibromyalgia, or severe knee osteoarthritis (OA). Davies et al. demonstrated that restoring sleep could predict resolution of chronic widespread pain. However, the underlying mechanisms linking impaired sleep and a reduction in pain inhibition are still unclear. Certain neurotransmitters such as serotonin and brain areas such as the periaqueductal gray matter are known to modulate both sleep stages and nociception, and may partly explain the association between impaired sleep and reduction in pain inhibition.
Nonetheless, little is known about the effect of sleep impairment on central pain mechanisms in clinical cohorts. This is important since it is still unclear if restoring a good quality of sleep can modulate the central pain pathway changes known to occur when having impaired sleep and/or chronic pain.
One approach to this question is to assess patients known to suffer from sleep impairment. In this respect, obstructive sleep apnea (OSA) patients are known to present with worsened sleep due to the collapse of the pharyngeal musculature throughout the night. This leads to excessive daytime sleepiness and a decrease in quality of life. Furthermore, pain tolerance has been shown to be decreased in elderly who are diagnosed with OSA. However, little is known about OSA patients and pain sensitivity, and if the sleep impairment also affects the central pain pathways. If so, this may provide an important first step in understanding the possible benefit of restoring restoring normal regular sleep, as routinely achieved through gold standard treatment, and if this can modulate central changes known to occur in chronic pain patients.
Therefore, this project will focus on obstructive sleep apnea (OSA) patients to investigate if central pain mechanisms are affected by poor sleep and if golden standard sleep therapy through continuous positive airway pressure (CPAP) improves central pain mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea patients | – | Device: Continuous Positive Airway Pressure (CPAP)This group of patients will have been monitored over night with cardiorespiratory monitoring (CRM). CRM enables the physician to establish an Apnea-Hypopnea Index (AHI) which will be used for diagnosis. An AHI > 15 is considered moderate-to-severe sleep apnea, and this is the focus group of patients in the current project. These patients will be followed for 12 months during continuous positive airway pressure (CPAP) treatment. Adherence to the CPAP treatment will be closely monitored. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women presenting with an apnea-hypopnea (AHI) index > 15 (moderate-to-severe sleep apnea) measured by cardiorespiratory monitoring (CRM) [10] and scheduled for treatment at Søvncenter Nord
Key inclusion criteria (2 listed)
- Men and women presenting with an apnea-hypopnea (AHI) index > 15 (moderate-to-severe sleep apnea) measured by cardiorespiratory monitoring (CRM) and scheduled for treatment at Søvncenter Nord
- Age 18-80
Key exclusion criteria (5 listed)
- Pregnancy
- Intake of drugs labelled with the red warning triangle and misuse of cannabis and opioids
- No previous or current neurologic or mental illnesses
- Lack of ability to cooperate
- Non-fluent in Danish (reading, speaking, and comprehension)
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)CPAP is golden standard treatment for moderate-to-severe sleep apnea with high compliance, effectiveness, and cost-effectiveness. There will be no interference with standard care. | Device | Sleep apnea patients |
Primary outcome
Change in daytime sleepiness due to sleep apnea
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Daytime sleepiness as assessed by Epworth Sleepiness Scale, will be evaluated as a change from before treatment initiation (min value: 0 (no daily sleepiness); max value (24) - higher score associated with increased sleepiness)
5 secondary outcomes
Change in pain inihibition and facilitation
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
PainDetect
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Pain Catastrophizing Scale
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Pain intensity
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Continuous Positive Airway Pressure compliance (percentage who continues using the device for the optimum amount of time each night) and adherence (the percentage of patients who abandon treatment completely)
Time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment
Results and safety
The study was stopped early (reason given: Recruitment was made near impossible due to circumstances surrounding the epidemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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.
Dennis B Larsen, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Chronic Pain Syndrome, run by Aalborg University at 1 site in Denmark.
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: stopped early, as of the sponsor's last update on 6 Feb 2023. 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 Denmark. 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. 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?
The study was stopped early (reason given: Recruitment was made near impossible due to circumstances surrounding the epidemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daytime sleepiness due to sleep apnea (time frame: Baseline - 1 month- 12 months after initiation of sleep apnea treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.