Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397365
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-23
Brief Title:
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure
Sponsor:
Solelhac Geoffroy
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypnOSA
Brief Summary:
The prevalence of sleep-disordered breathing is high with an apnea-hypopnea index of over 15 per hour found in 497 of men and 234 of women in the general population 1 The gold standard treatment for sleep-disordered breathing is continuous positive airway pressure CPAP therapy 2 However nearly 30 of patients are considered non-adherent to CPAP treatment 3 Moreover the number of hours of CPAP usage has been shown to be directly associated with a reduction in objective and subjective sleepiness and improvement in daytime functioning 4 A recent prospective study conducted in a French clinical population cohort of 5138 participants found an effect of CPAP treatment duration on reducing the risk of developing a major cardiovascular event stroke myocardial infarction all-cause mortality 5 Therefore the poor adherence to CPAP treatment represents a public health challenge for healthcare professionals managing these patients Several predictors for non-adherence can be identified such as using CPAP for less than 4 hours per night during the initial treatment phase moderate to severe obstructive sleep apnea or low self-esteem 6 Measures aimed at promoting patient adaptation from the initiation of treatment are crucial as this period determines long-term adherence to CPAP therapy 7 Among these measures there is the management of physical adverse effects such as xerostomia using a humidifier feeling too much or too little air modifying CPAP pressure profiles skin problems and mask air leaks interface adjustment which are well-known and applied by health care organization providing the CPAP machines 2
On top of these technical problems patients related issues such as mask-induced anxiety psychosocial conditions and dysfunctional thoughts about CPAP treatment may prevent patients from using their CPAP properly Innovative tools such as psycho corporal therapies including medical hypnosis could be used in these situations A recent literature review focusing on the impact of medical hypnosis on sleep disorders in adult patients found an improvement in various sleep parameters sleep quality insomnia complaints frequency andor intensity of parasomnias in 584 of patients However in this systematic review of 24 studies none of them explored the use of medical hypnosis in sleep-related breathing disorders 8
Hypnosis can be defined as an altered state of consciousness in which a persons attention is detached from their immediate environment and absorbed in inner experiences such as feelings cognition and imagery 9 Hypnotic induction involves focusing attention and imaginative involvement to the point where what is imagined seems real By using and accepting suggestions the clinician and the patient create a benevolent hypnotic reality with the goal of improving the patients clinical situation 10
In the literature there is only one clinical case report describing a benefit of medical hypnosis for CPAP tolerance in a child with cherubism a rare fibro-osseous genetic disease-causing nasal obstruction In this case CPAP therapy using an oral interface was fully accepted after three hypnosis sessions and corrected the obstructive sleep breathing disorder 11 In a slightly different domain there is a case report of successful use of medical hypnosis as an adjunct therapy for weaning from mechanical ventilation 12
Our hypothesis is that the use of medical hypnosis in CPAP-treated patients could improve the patients perception of the treatment making it more positive Medical hypnosis could occur very early in the management process with rapid learning of self-hypnosis to actively influence this crucial period for long term adherence of CPAP The principal objective is therefore to evaluate the effects of medical hypnosis on adherence to CPAP therapy in patients with sleep-disordered breathing
On top of these technical problems patients related issues such as mask-induced anxiety psychosocial conditions and dysfunctional thoughts about CPAP treatment may prevent patients from using their CPAP properly Innovative tools such as psycho corporal therapies including medical hypnosis could be used in these situations A recent literature review focusing on the impact of medical hypnosis on sleep disorders in adult patients found an improvement in various sleep parameters sleep quality insomnia complaints frequency andor intensity of parasomnias in 584 of patients However in this systematic review of 24 studies none of them explored the use of medical hypnosis in sleep-related breathing disorders 8
Hypnosis can be defined as an altered state of consciousness in which a persons attention is detached from their immediate environment and absorbed in inner experiences such as feelings cognition and imagery 9 Hypnotic induction involves focusing attention and imaginative involvement to the point where what is imagined seems real By using and accepting suggestions the clinician and the patient create a benevolent hypnotic reality with the goal of improving the patients clinical situation 10
In the literature there is only one clinical case report describing a benefit of medical hypnosis for CPAP tolerance in a child with cherubism a rare fibro-osseous genetic disease-causing nasal obstruction In this case CPAP therapy using an oral interface was fully accepted after three hypnosis sessions and corrected the obstructive sleep breathing disorder 11 In a slightly different domain there is a case report of successful use of medical hypnosis as an adjunct therapy for weaning from mechanical ventilation 12
Our hypothesis is that the use of medical hypnosis in CPAP-treated patients could improve the patients perception of the treatment making it more positive Medical hypnosis could occur very early in the management process with rapid learning of self-hypnosis to actively influence this crucial period for long term adherence of CPAP The principal objective is therefore to evaluate the effects of medical hypnosis on adherence to CPAP therapy in patients with sleep-disordered breathing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None