Closed-Loop Neuromodulation for Anti-Habituation Sleep Therapy

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Solution Overview

Problem

Current sleep therapy devices often disrupt sleep states or wake patients, fail to adapt to changing patient conditions, and are not autonomous, leading to habituation and reduced effectiveness in treating sleep disorders.

Innovation Solution

A closed loop neuromodulator that automatically adjusts stimulation intensity and type based on real-time patient feedback, using an EMI/ESD hardened sensor interface, activity detector, stimulus timer, stimulus generator, and sequencer to optimize therapy without requiring continuous practitioner intervention, and is designed to operate effectively in diverse environments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If stimulation intensity is increased to ensure effective treatment of sleep disorders, then treatment effectiveness is improved, but patient may be awakened or sleep state disrupted

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidsleep disruption

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device dynamically adjusts stimulation parameters in real-time based on detected sleep disorder events and habituation indicators. The stimulation intensity, frequency, and pattern are continuously modified to maintain therapeutic effectiveness while adapting to changing patient conditions and preventing sleep disruption.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes multiple stimulation parameters simultaneously including intensity, pulse width, frequency, and inter-stimulus intervals. By varying these parameters in response to detected habituation, the device maintains treatment effectiveness without causing sleep disruption or patient awakening.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If stimulation parameters remain constant to simplify device operation, then ease of operation is improved, but habituation occurs reducing treatment effectiveness

Engineering Contradiction:

Improvedevice operation simplicityVSAvoidtreatment effectiveness

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The device autonomously monitors patient response and automatically adjusts stimulation parameters to prevent habituation. The system detects sleep disorder events, evaluates treatment effectiveness, and modifies stimulation patterns without requiring practitioner intervention, thereby maintaining both ease of operation and treatment effectiveness.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system implements closed-loop feedback by continuously monitoring patient physiological signals and using this information to adjust stimulation parameters. The feedback mechanism detects habituation indicators and automatically modifies the stimulation regimen to maintain treatment effectiveness while simplifying operation.

Inventive Principle:

Principle #23Feedback

3Reliability

If continuous practitioner intervention is required to adjust stimulation parameters, then treatment effectiveness is improved, but device complexity and loss of time increase

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidsystem complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device performs self-adjustment of all critical stimulation parameters based on automated detection of sleep disorder events and habituation indicators. The system independently evaluates treatment effectiveness and modifies stimulation patterns, eliminating the need for continuous practitioner intervention while maintaining high treatment effectiveness.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The device is pre-programmed with algorithms to detect sleep disorder events, evaluate treatment response, and adjust stimulation parameters to prevent habituation. These preliminary automated actions reduce the need for practitioner intervention and simplify the overall system operation.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If stimulation is applied frequently to prevent habituation, then treatment effectiveness is improved, but sleep disruption and patient awakening increase

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidsleep disruption

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system applies stimulation in periodic bursts synchronized with detected sleep disorder events rather than continuous application. By timing stimulation to coincide with apnea events or other disorder manifestations, the device maintains treatment effectiveness while minimizing sleep disruption and patient awakening.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The device dynamically adjusts the frequency and timing of stimulation based on real-time detection of sleep disorder events and patient response. This dynamic approach allows frequent stimulation when needed to prevent habituation while avoiding stimulation during stable sleep periods, thereby maintaining effectiveness without causing sleep disruption.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS8834347B2Anti-habituating sleep therapy for a closed loop neuromodulator

Publication Date: 2014.09.16 DYMEDIX CORP

AI summary

This document discusses, among other things, a system and method for anti-habituating sleep therapy using a closed loop neuromodulator. A first sleep disorder event can be detected using first activity information, and a first series of stimuli can be provided, in response to the first sleep disorder event, using a set of stimulus parameters. A habituation event can be detected and anti-habituation stimulation parameter can be adjusted to avoid patient habituation to the stimuli.