Sleep and Pain Sensitivity

NCT04246294 | Terminated

• 1 other identifier: N-20190044
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline - 1 month- 12 months after initiation of sleep apnea treatment

Secondary Outcomes (5)

• Change in pain inihibition and facilitation

  Baseline - 1 month- 12 months after initiation of sleep apnea treatment

• PainDetect

  Baseline - 1 month- 12 months after initiation of sleep apnea treatment

• Pain Catastrophizing Scale

  Baseline - 1 month- 12 months after initiation of sleep apnea treatment

• Pain intensity

  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)

  Baseline - 1 month- 12 months after initiation of sleep apnea treatment

Study Arms (1)

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.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

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.

Sleep apnea patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Sleep Center North, Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Dennis B Larsen, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 29, 2020
• Study Start: February 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)