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Recruiting NCT07011966

ASV Therapy for Insomnia

No phase Interventional Insomnia Insomnia (Moderate)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ASV therapy.
Who it may be relevant to
Registry conditions: Insomnia, Insomnia (Moderate). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia

Overview

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.

Detailed 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.

Interventions

  • Device ASV therapy
    Adaptive servo ventilation (ASV) therapy using ResMed AirCurve 11 device will be used to target potential upper airway resistance and respiratory related arousals in patients with insomnia. The ASV device is approved for the treatment of obstructive sleep apnea, and this will be designated as the investigational device for this study with appropriate labelling.

Primary outcome measures

  • Insomnia Severity Index (ISI) score [Time frame: 4 weeks after therapy start]
Secondary outcome measures (1)
  • Sleep Onset Latency [Time frame: 4 weeks after treatment initiation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • C.S. Mott Center — Detroit

Identifiers

NCT: NCT07011966 · SLP-25-01-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗