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New treatment option for Insomnia
Official title ASV Therapy for Insomnia
ClinicalTrials.gov ID: NCT07011966
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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...
You likely can't join if
- 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.
See the full eligibility 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.