ASV Therapy for Insomnia

ResMed

Status

Not yet enrolling

Conditions

Insomnia (Moderate)

Insomnia

Treatments

Device: ASV therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT07011966

SLP-25-01-01

Details and patient eligibility

About

This will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.

Full description

The primary objective of the study is to evaluate the effectiveness of adaptive servo ventilation therapy to reduce insomnia severity in primary insomnia patients.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 years old
Complaint of insomnia when presenting at clinic
Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB
Owns a smartphone and is able to install an application for HSAT data syncing.
Able to fully understand study information in English and sign informed consent

Exclusion criteria

Primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness
Pregnant or planning to be pregnant
Any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
High risk for moderate to severe OSA based on STOP-BANG score.
BMI > 40 kg/m2
Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial.
Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints.
Daily use of opiate medications
Known contraindications to PAP therapy as listed in the indication for use (i.e. heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤45%) and moderate to severe predominant central sleep apnea).
Inability to pre-emptively comply with study procedures
Patients who wish to continue using sleeping pills/hypnotics during the study
Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint.