The Impact of Arousal Threshold in Obstructive Sleep Apnea

Status Completed

Clinical Trial Summary

The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

Clinical Trial Description

This study is a pilot study. The investigators will test whether donepezil has important effects on the arousal threshold and on the apnea hypopnea index.

Donepezil is a cholinesterase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptoms of Alzheimer's disease.

Eligible participants will undergo overnight polysomonography as described below and will receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order) followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30 subjects.

The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will be compared in the donepezil groups with the placebo group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02264353
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Completed
Phase	Phase 4
Start date	September 2014
Completion date	May 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05857384` - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs	Phase 1
Recruiting	`NCT04547543` - Follow-up of Apneic Patients by Visio-consultation	N/A
Recruiting	`NCT05371509` - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study	N/A
Completed	`NCT02515357` - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea	N/A
Completed	`NCT05582070` - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction	N/A
Active, not recruiting	`NCT03189173` - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea	Phase 2
Completed	`NCT04084899` - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed	`NCT03032029` - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting	`NCT04028011` - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting	`NCT06047353` - Community Health Advocates for Motivating PAP Use in Our Neighborhoods.	N/A
Completed	`NCT05253963` - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea	N/A
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT06150352` - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed	`NCT03589417` - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting	`NCT04335994` - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing	N/A
Withdrawn	`NCT04063436` - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea	N/A
Recruiting	`NCT05385302` - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting	`NCT04572269` - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting	`NCT06467682` - 12-week Tele-exercise Program in Patients With OSA	N/A
Withdrawn	`NCT04011358` - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study	N/A